SYNTHES GMBH QUICK COUPLING FOR DRILL BITS F/BPL; MOTOR, SURGICAL INSTRUMENT, AC-POWERED
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Catalog Number 530.750 |
Device Problems
Device-Device Incompatibility (2919); Mechanical Jam (2983)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/14/2023 |
Event Type
malfunction
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Event Description
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It was reported from india that during service and evaluation, it was determined that the quick coupling device was frozen/would not move and failed pre-test for check function of collar on the tool coupling, check tool coupling and check general function in the running mode.It was noted in the service order that the device was not holding the drill bit.This event did not occur during surgery.There was no patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, an additional report will be submitted accordingly.
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Manufacturer Narrative
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This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: the actual device was returned for evaluation.During evaluation it was determined that the initial reported condition of the device was not confirmed.Therefore, the assignable root cause was not determined.However, the malfunctions found during service and evaluation have been confirmed.The assignable root cause was determined to be due to component wear.Udi:(b)(4).
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