Model Number N/A |
Device Problem
Device Inoperable (1663)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/24/2017 |
Event Type
malfunction
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Manufacturer Narrative
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Zimmer biomet complaint (b)(4).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.Multiple mdr reports were filed for this event, please see associated report: 0001032347-2017-00822.
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Event Description
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It was reported the gears stripped in two drivers during a rib plating procedure.The surgical technique for the product was utilized.The event did not result in a delay or injury to the patient.
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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.The drivers were visually evaluated and found to be in good overall condition; some discoloration was observed.The knob rotates with some friction on both drivers.The drivers were functionally tested by driving a screw into a white oak block and were found to insert the screw with difficulty due to the friction felt when turning the knob.The drivers were disassembled and found to have significant discoloration and stripped gear teeth.If additional torque is applied after the screw is seated it is possible that the internal gearing of the driver can be overcome.Device history record (dhr) was reviewed and no discrepancies were found.Investigation results concluded that the reported event was due to excessive force.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.Multiple mdr reports were filed for this event, please see associated report: 0001032347-2017-00822-1.
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Search Alerts/Recalls
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