In a rare exception to the FDA’s normal practice, the agency posted a Form 483 flagging several GMP and MDR nonconformities — most of which are repeat observations — at a Zimmer Biomet medical device manufacturing facility in Indiana.
Out of the eight nonconformities the FDA investigators noted, five were first observed during site inspections dating back to 2011 or 2015, with the last one concluding in October 2017. The firm’s CAPA procedures and lack of written MDR procedures are among those flagged on more than one occasion.
A CAPA investigation regarding the use of existing nonconforming products was closed last August after the firm initiated a recall of its Class II hip and Class II/III knee implants to address a customer complaint “alleging that a surgeon opened a femoral implant and found parts of the plastic bag sticking to the implant,” the FDA said.
In an attempt to correct the problem, the firm acted to replace the implants’ old Low Density Polyethylene bag with a new one for future packaging, and concluded the complaint investigation by stating that “the plastic bag sticking on the implant was the ‘old style poly bag,’” the FDA investigators said. But the “scope of the containment action was not sufficient to correct and prevent the recurrence of the nonconformity.” The issue was first noted in 2011.
In addition, Zimmer Biomet had yet to implement written MDR instructions for at least four of its procedures, including those for complaint handling and device reporting, that the FDA reviewed during inspections in 2015 and 2017. The procedures “do not ensure that MDRs for serious injuries are reported as required,” the investigators added. A total of 55 instances were identified as serious injuries that should have been reported to the FDA via MDR submissions.
Another repeat observation relates to the firm’s device packaging procedure, which did not provide “adequate assurance that all packaging systems will provide physical protection and maintain the integrity of the sterile barrier system through normally anticipated hazards associated with shipping.” And its climate conditioning for new or design-changed products differed from those “required for legacy packaging configurations,” according to the FDA.
The firm’s inadequate procedures for ensuring all pieces of equipment are routinely calibrated as required and a complaint handling procedure that did not describe a mechanism for determining complaint status are the remaining two repeat observations.
Newly identified issues relate to an inefficient control of nonconforming products, including those found to have been contaminated, a lack of Issue Evaluations for at least four instances of exceeded control limits, as well as a validation process performed on software being used for making quality hold determinations that did not conform to specified requirements.
Read the Zimmer Biomet Form 483 here: www.fdanews.com/02-08-18-Zimmer.pdf. — Ana Mulero
Medical Device Reporting Requirements
MDR requirements are an outgrowth of complaint management regulations. The FDA’s regulations in 21 CFR Part 803 – Medical Device Reporting require that companies evaluate all device complaints to determine if they involve an adverse event that must be reported to the agency.
Malfunctions must be reported when the chance of death or serious injury resulting from recurrent malfunctions is not remote. Malfunctions also need to be reported when the consequences of the malfunction affect the device in a catastrophic manner that might lead to a death or serious injury.
Manufacturers often have the most trouble determining when the likelihood of a future malfunction resulting in death or serious injury is not remote. One of the factors the FDA looks at is whether or not that particular type of malfunction has caused a death or serious injury in the past two years. If it has, the agency concludes that the risk is not remote and the event must be reported.
In addition, manufacturers must report malfunctions when:
The timeline for reporting an event to the FDA depends on the immediacy and severity of the problem. Manufacturers must submit an MDR either within 30 days of becoming aware of an event or, in the case of possible “unreasonable risk of substantial harm to the public health,” within five days of learning about the event.
Excerpted from the FDAnews management report: Complaint Management for Devicemakers — From Receiving and Investigating to Analyzing Trends.