Model Number N/A |
Device Problem
Fracture (1260)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/15/2023 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The customer has indicated that the product will not be returned to zimmer biomet for investigation as its location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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Event Description
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It was reported that the pin on the version guide broke.There was no known impact or consequences to the patient.Attempts have been made and no further information has been provided.
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Event Description
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No further event information is available at the time of this report.
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Manufacturer Narrative
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No product was returned; however, a picture was provided and reviewed.A visual examination of the provided picture identified the guide to be broken as reported.Lot identification is necessary for review of device history records; lot identification was not provided.The reported event is not related to a combination of products; therefore, a compatibility review is not applicable.Medical records were not provided.The event is confirmed via the provided photo.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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Search Alerts/Recalls
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