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 11/10/2022 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Report source: foreign: japan.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.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 the during surgery, the anchor came out from the patients burr hole while attached to the tip of the device although the surgeon implanted it following the normal usage.It is also noted that the tip of the inserter was fractured along with the anchor.Attempts have been made and additional information on the reported event is unavailable at this time.
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Manufacturer Narrative
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Upon evaluation of returned device, it was determined to be not reportable as the returned anchor was not fractured.No serious injury or harm to the patient reported for this event or prior events with same or similar products.The initial report should be voided.
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Event Description
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Upon evaluation of returned device, it was determined to be not reportable as the returned anchor was not fractured.No serious injury or harm to the patient reported for this event or prior events with same or similar products.The initial report should be voided.
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Search Alerts/Recalls
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