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Catalog Number 05.001.201 |
Device Problems
Separation Failure (2547); Device-Device Incompatibility (2919)
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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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Manufacturer Narrative
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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.Concomitant med products: saw device initial reporter name and address: reporter's phone number was not provided as of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.Udi (b)(4).
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Event Description
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It was reported from (b)(6) that during a collective knee replacement surgical procedure using a battery handpiece device it was observed that the head of the saw device tended to come off the handpiece device during placement, and the cover that closes the battery device was not completely adjusted.It was reported that during the surgery the device only came off once, and the procedure was able to be completed without any setback.It was reported that there was no delay in the procedure due to the event.There was patient involvement reported.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 2022.All available information has been disclosed.If additional information should become 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.H10 additional narrative: as of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.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.
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Search Alerts/Recalls
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