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Model Number N/A |
Device Problem
Device Contaminated During Manufacture or Shipping (2969)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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Zimmer biomet complaint (b)(4).Concomitant medical product: battery powerdriver p2, cat #5050-1010, lot # 147280, battery powerdriver p2, cat #5050-1010, lot # 386850, battery powerdriver p2, cat #5050-1010, lot # 407260.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2021-00508, 0001032347-2021-00510, 0001032347-2021-00511.Mfr site: (b)(4).
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Event Description
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It was reported that during receiving inspection foreign material was discovered in the sterile package.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.No product was returned.Photos were provided and the following was identified: item# 50-1010 lot# 147260 was verified item/lot to complaint.Two photos reviewed and identified black hair/fiber and hair/fiber.Material cannot be determined.Size can not be verified.Inspection criteria i00051.3 packaging inspect outlines acceptable standards for packaging debris within packaging requirements section.Debris size acceptability cannot be determined from supplied photos.Review of the device history record(s) identified no deviations or anomalies during manufacturing the condition of the device when it left zimmer biomet is non-conforming to specification.The root cause of the reported event is the operator not following the work instructions provided.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.This report is being submitted to update additional information in section b4, b5, g3, g6, h2, h3, h6 and h10.Corrected information: d4.
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Event Description
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No further event information is available at the time of this report.
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Search Alerts/Recalls
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