STRYKER TRAUMA KIEL TARGET DEVICE GAMMA3®; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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Model Number 1320-0111 |
Device Problem
Mechanical Jam (2983)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/04/2022 |
Event Type
malfunction
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Event Description
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As reported: "surgeon impacted nail with sleeve assembly instead of the strike plate.During insertion of the k-wire, the k-wire hit the nail and the k-wire could not be removed from the sleeve.At the end of the case, it was noticed that the nail holding bolt was stuck in the targeting arm.The impaction was done with the sleeves on the nail holding bolt.Another set was opened and replacement parts used.".
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Manufacturer Narrative
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Upon completion of the investigation, additional information will be provided in a supplemental report.
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Manufacturer Narrative
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Correction: please refer to d9/h3 - device not returned.The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.A device inspection was not possible since the affected device was not returned, and no other evidence were provided for investigation.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.The instructions for use instructs user that: ¿during the procedure, repeatedly check that the connections between the instruments or between implants and instruments required for the precise positioning and fixing are secure.¿ more detailed information about the complaint event as well as the affected device must be available to determine the root cause of the complaint event.If the device is returned or if any additional information is provided, the investigation will be reassessed.H3 other text : device disposition is unknown.
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Event Description
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As reported: "surgeon impacted nail with sleeve assembly instead of the strike plate.During insertion of the k-wire, the k-wire hit the nail and the k-wire could not be removed from the sleeve.At the end of the case, it was noticed that the nail holding bolt was stuck in the targeting arm.The impaction was done with the sleeves on the nail holding bolt.Another set was opened and replacement parts used.".
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