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Catalog Number 530.710 |
Device Problems
Output below Specifications (3004); Physical Resistance/Sticking (4012)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/01/2022 |
Event Type
malfunction
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Event Description
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It was reported by switzerland that during service and evaluation, it was determined that the battery oscillator device failed visual inspection, had low power and damaged component.It was further determined that the device had a sticky trigger and the locking mechanism was loose.It was observed that the saw head locking mechanism was cracked.It was further determined that the device failed pretest for general condition, check the quick coupling for saw blades, check for sticky trigger and check oscillation frequency with frequency meter.It was noted in the service order that the device had low power.This event did not occur during surgery.There was no patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.The exact date of the event was unknown.However, it was reported that the event occurred in 2022.All available information has been disclosed.If additional information should available, a supplemental medwatch 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 this medwatch, a supplemental medwatch report will be filed as appropriate.The actual device was returned for evaluation.Quality engineering evaluated the device and determined that the reported condition that the device had a sticky trigger, identified during service and repair, was confirmed.The assignable root cause of the cracked saw head locking mechanism was determined to be traced to device design, which has been escalated to capa.Further results of the analysis will be captured under the capa.The assignable root cause of the remaining malfunctions found during service and repair was determined to be due to component failure from wear.A device history review was performed which indicated that there were no relevant issues identified during the manufacture of the device that may have contributed to the reported condition.Udi: (b)(4).
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Search Alerts/Recalls
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