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Model Number PNCH, MD 15 UP TP, 3.4 STR, W/FLUSHPORT |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/21/2023 |
Event Type
malfunction
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Manufacturer Narrative
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The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
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Event Description
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It was reported that during an anterior cruciate ligament surgery the shaft broke.There was no harm for patient, operator or third party reported.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.Update dw 01-dec-2023 further information were provided that the broken pieces were retrieved out of the patient.
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Search Alerts/Recalls
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