Model Number N/A |
Device Problem
Deformation Due to Compressive Stress (2889)
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Patient Problem
No Code Available (3191)
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Event Date 07/30/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical product: medical product-vpc screw 2.5x16mm, catalog#: 233225016, lot#:unk.Multiple mdr reports were filed for this event, please see associated reports: 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.
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Event Description
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It was reported that during a bunion procedure, while the surgeon was attempting to implant two screws, both screw heads stripped upon implantation.In conclusion, both screws were removed from the patient and the surgery was successfully completed with another device.No additional adverse events were a result of this malfunction.
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Event Description
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It was reported that during a bunion procedure, while the surgeon was attempting to implant two screws, both screw heads stripped upon implantation.In conclusion, both screws were removed from the patient and the surgery was successfully completed with another device.No additional adverse events were a result of this malfunction.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.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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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2018-08845-1.Complaint sample was evaluated and the reported event was confirmed.The products were returned and evaluated.The head of the screws is stripped.Under magnification, it appears that the internal geometry is at least present.Without seeing the driver bit, it¿s unknown if the screw heads dimensions are correct or the driver bit is correct.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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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Event Description
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No further event information available at the time of this report.
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Search Alerts/Recalls
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