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Catalog Number 511.417 |
Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 08/07/2017 |
Event Type
malfunction
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Manufacturer Narrative
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Udi - (b)(4).Reporter's phone number was not provided.The actual device has been returned and is currently pending evaluation.Once the evaluation of the device has been completed, a supplemental medwatch report will be sent accordingly.
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Event Description
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This is report 9 of 9 for the same event.It was reported from (b)(6) that during a surgical procedure for a tibial diaphysis fracture, it was observed that the drill bit devices stopped moving during the insertion of distal side locking using a radiolucent drive adaptor device, radiolucent drive device, and a battery handpiece device.It was reported that when the devices were checked on the instrument table, it was observed that the radiolucent drive device was spinning around.As a result, the side stopping was inserted manually.It was reported that there was a 20 minute delay in the procedure due to the event.It was not reported if spare devices were available for use.There was patient involvement reported.There were no patient or user injuries reported.It was reported there was no medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
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Manufacturer Narrative
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This device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.During repair, it was determined that the device passed all operational specifications and no failure was identified.Therefore, the reported condition was not confirmed and an assignable root cause was not determined.If additional information should become available, a supplemental medwatch will be submitted accordingly.
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Search Alerts/Recalls
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