Model Number N/A |
Device Problem
Difficult to Remove (1528)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 10/10/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Medical products: headless trocar drill pin # 00590102000 lot # 63756777.(b)(4).It is unknown if product will be returning to zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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Event Description
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It was reported that during a knee surgery, the surgeon found the drill pin was stuck in the cut guide when he was aligning the tibial cut guide for the proximal tibia osteotomy.The same guide was used to complete the procedure.No adverse events have been reported as a result of the malfunction.Attempts have been made and additional information on the reported event is unavailable.
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Manufacturer Narrative
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Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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Manufacturer Narrative
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Complaint sample was evaluated and the reported event was confirmed.Visual evaluation of the returned tibial cut guide showed that the drill pin is lodged in one of the pilot holes therefore unable to perform a dimensional check on the diameter of the hole.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Review of the complaint history determined that no further action(s) is/are required.Root cause was unable to be determined.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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