Model Number N/A |
Device Problem
Disassembly (1168)
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Patient Problem
Foreign Body In Patient (2687)
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Event Date 02/14/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).(b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr 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.Remains implanted.
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Event Description
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It was reported that the retaining screw of the internal pin mounted on the spring disconnected from and fell into the surgical site.After the surgeon identified the location of the screw, he elected to leave it in-vivo.
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Event Description
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No further event information available at the time of this report.
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Manufacturer Narrative
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This follow-up report is being submitted to relay updated and additional information.Complaint sample was evaluated and the reported event was confirmed.The stemmed tibial broach impactor was returned with the guide pin still affixed to the shaft, the shaft still assembled to the guide, and the spring still contained within the guide.However, the locating pin and the thumb pin were not returned.The thumb pin fell in the wound during surgery and was retained by the patient.Dhr was reviewed and no discrepancies were found.Investigation results concluded that the reported event was due to a design issue and a distribution error.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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Search Alerts/Recalls
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