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Catalog Number 530.710 |
Device Problems
Device Damaged Prior to Use (2284); Noise, Audible (3273); Physical Resistance/Sticking (4012)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/02/2023 |
Event Type
malfunction
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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.H10 additional narrative: service review: a review of the service history record indicates that the device was serviced over a year for a service condition that is not relevant to the current reported condition.Device evaluation: the actual device was returned for evaluation.During repair, an evaluation was performed, and it was determined that the reported condition of the device making an abnormal noise was not confirmed.Therefore, an assignable root cause was not determined.However, the sticky trigger, identified during service and evaluation was confirmed.The assignable root cause was determined to be due to component failure from normal wear.Udi: (b)(4).
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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 trigger of the battery oscillator device was sticky.The device was visually and functionally inspected, and it was found that the electrical ports of the device were damaged and the color on the control unit was fading.It was further determined that the device failed pretest for general condition and check for sticky trigger.It was noted in the service order that upon delivery of the device, it was confirmed that it made an abnormal noise.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, a supplemental medwatch will be submitted accordingly.
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Search Alerts/Recalls
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