STRYKER GMBH STERILE FIELD KIT HOFFMANN 3 KIT B; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
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Model Number 4922-9-941S |
Device Problem
Material Fragmentation (1261)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/03/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Upon completion of investigation, additional information will be provided in a supplemental report.
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Event Description
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As reported: "when i used the drill brace and inserted the apex pin, a piece of metal came out of the drill brace.The operation continued as it was and was completed without any problems.".
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Manufacturer Narrative
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The reported event could not be confirmed since no debris were found on the device.The visual inspection showed that the device is in a good state overall.No major damage was noticed.However, the surface of the pin's head is slightly damaged.Probably, high forces were applied while using the instruments.Therefore, the debris reported in the complaint may be generated by the damage of the rod.However, the functional inspection showed that the device is fully functional and that no debris were generated or found.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.Based on investigation, the root cause was attributed to a user related issue.The failure was most probably caused by a mishandling of the device.If any further information is provided, the complaint report will be updated.
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Event Description
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As reported: "when i used the drill brace and inserted the apex pin, a piece of metal came out of the drill brace.The operation continued as it was and was completed without any problems.".
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