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Biomet Spine 483 Relates to Validation Records, Complaints

January 20, 2015

FDA investigators handed Biomet Spine a four-observation Form 483 for deficiencies with validation records and complaint-handling problems.

A protocol at the Broomfield, Colo., facility set certain acceptance criteria for microbial contamination of water produced by a system. But reports documented in the lab exceeded the acceptance criteria and Biomet Spine did not investigate the elevated microbial counts. Instead, the devicemaker changed the acceptance criteria in the report, according to the form.

Another observation relates to Biomet Spine’s handling of a complaint that documented a patient death during a procedure using a Timberline retractor to remove an artificial disc. According to the complaint record, the sales representative indicated the retractor did not contribute to the death. But there was no documentation of information supporting this statement from a person qualified to make a medical judgment, the form says. And Biomet Spine did not report the death to the FDA as an MDR.

The company also failed to report a recall of 120 Durango Anchored Anterior Lumbar Interbody Fusion Plate Sets following two complaints of set screws dislodging from the plates.
Biomet Spine did not return a request for comment by press time.

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