STRYKER TRAUMA KIEL LOCKING SCREW, FULLY THREADED T2 HUMERUS Ø4X34 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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Model Number 1896-4024S |
Device Problem
Fracture (1260)
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Patient Problem
Failure of Implant (1924)
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Event Date 08/26/2021 |
Event Type
Injury
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Manufacturer Narrative
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The device has not been returned.If additional information becomes available, it will be provided in a supplemental report.Device remains implanted.
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Event Description
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It was reported a revision of the surgery performed about a year ago was scheduled due to confirmed postoperative screw fracture.However, before the revision, a mistake in ordering the instruments was discovered and the surgery was postponed.The patient was under general anesthesia.Revision surgery was rescheduled for (b)(6) 2021.This record captures the postoperative screw fracture.
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Manufacturer Narrative
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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 for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.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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It was reported a revision of the surgery performed about a year ago was scheduled due to confirmed postoperative screw fracture.However, before the revision, a mistake in ordering the instruments was discovered and the surgery was postponed.The patient was under general anesthesia.Revision surgery was rescheduled for (b)(6) 2021.This record captures the postoperative screw fracture.
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