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Model Number N/A |
Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 11/20/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Medical devices, jgrknt single 1.4mm 1 #1 mb, p06371.Report source, foreign ¿ events occurred in (b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2017 - 11480.
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Event Description
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It was reported that during surgery the anchors were pulled out without becoming lumped up after the surgeon inserted them into the patient's burr holes.Attempts have been made and additional information on the reported event is unavailable.
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Manufacturer Narrative
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Complaint sample was evaluated and the reported event was confirmed.Visual review identified some minor damage to the threads of the anchor, indicating use.The anchor is completely separated from the suture.The device is also disassembled from the inserter, further indicating attempted use.Functional testing is not possible as the device was returned disassembled.There are no visual indications that the device should have failed.Without the opportunity to be present at the time of the procedure, root cause cannot be determined.Device history record was reviewed and no discrepancies relevant to the reported event were found.Review of the complaint history determined that no further action is required 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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