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Catalog Number 530.710 |
Device Problems
Fracture (1260); Physical Resistance/Sticking (4012)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/01/2023 |
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.Device evaluation: the actual device was returned for evaluation.During repair, an evaluation was performed and it was determined that the saw head locking mechanism of the battery oscillator device was cracked and the trigger of the device did not move smoothly.It was determined that the cause for the cracked saw head is a confirmed design error and is captured under a capa.It was further determined that the assignable root cause of the trigger of the device did not move smoothly was traced to component failure due to wear.A review of the service history record indicates that the device has not been serviced for a service condition that is relevant to the current reported condition.Udi: (b)(4).
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Event Description
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It was reported from japan that the blade connecting part of the battery oscillator device was cracked.During in-house engineering evaluation in switzerland, it was observed that the saw head locking mechanism on the device was cracked and the trigger of the device did not move smoothly.It was further determined that the device failed pretest for visual inspection, general condition, check the quick coupling for saw blades, and check for sticky trigger.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 not reported, however, it was reported that the event occurred in 2023.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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