Catalog Number 110010733 |
Device Problem
Fracture (1260)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/05/2024 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.
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Event Description
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It was reported that during the procedure, while drilling for the acetabular screw, the drill bit was fractured.There was no harm or health consequences to the patient.It was reported that no further information is available.
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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: updated: b4; b5; g3; h2; h6.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.The complaint was unable to be confirmed as no product was returned or pictures provided.Device history record (dhr) was unable to be performed as the lot number of the device involved in the event is unknown.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Event Description
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No additional event information to report at this time.
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Search Alerts/Recalls
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