Model Number N/A |
Device Problem
Device Slipped (1584)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Type
malfunction
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Manufacturer Narrative
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(b)(4).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: 0001822565-2017-06708 and 0001822565-2017-06709.
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Event Description
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It was reported that during an open reduction internal fixation procedure of the femur, the guide wire instrument did not grip properly.Another instrument from another tray was utilized to complete the procedure.No adverse events have been reported as a result of the malfunction.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.Visual inspection noted impaction marks present on the product.The etching of the product is faded and scratches can be seen on the handle.The wear on the holes leads to insufficient gripping of guide wires.Dimensions taken were within specifications.A functional check was performed with a mating guide wire, and the 3.0 mm hole failed to securely grip guide wire.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.Based on the information available, the root cause can be determined as normal wear during the instrument¿s field life.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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