STRYKER TRAUMA KIEL U-BLADE INSERTER GAMMA3®; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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Model Number 1320-0340 |
Device Problems
Break (1069); Fracture (1260)
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Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/24/2022 |
Event Type
malfunction
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Event Description
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As reported: "during u-blade insertion, the pin of the inserter broke off.".
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Manufacturer Narrative
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Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.
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Manufacturer Narrative
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Correction: please refer to h6 clinical and health impact code.The reported event could not be confirmed since the device was not returned for evaluation and no other evidence was 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.Indications of material, manufacturing, or design related problems were unable to be identified as the lot number was not communicated.A review of the labeling did not indicate any abnormalities.More detailed information about the complaint event as well as the affected device must be available in order 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.
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Event Description
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As reported: "during u-blade insertion, the pin of the inserter broke off." additional information: no debris were left in the patient's body.The procedure was completed successfully using the freehand technique.
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Search Alerts/Recalls
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