(b)(6).The complaint device has been returned, but the device investigation has not yet been completed.Once the evaluation is completed, a supplemental medwatch 3500a will be submitted.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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This follow-up report is being submitted to relay additional information.The following has been updated: complaint sample was evaluated and the reported event was confirmed.Evaluation of the returned device confirmed that it is fractured at the tip, but still in one piece, and is showing signs of repeated use.Dhr was reviewed and no discrepancies were found.The instrument use, care, and sterilization booklet informs that end of life is determined by wear and damage due to use.Also, the insert recommends inspecting all instruments carefully prior to each use, and to functional test instruments with long slender features (particularly rotating instruments) for distortion.If damage or wear is noted that may compromise the function of the instrument, it should not be used.It was concluded that wear and tear is the root cause of the reported event.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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