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 11/21/2023 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).G2: foreign - canada.The 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 that during surgery, a piece of the flexible drill driver was torn off.The piece was retrieved from the acetabulum.There was no known impact or consequences to the patient.It was reported that no further information is available.
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Event Description
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No further information is available at the time of this report.
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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional information.One flexible silicone drill driver item# 110010733 lot# 174691 was returned and evaluated.Upon visual inspection the sheath had torn near the head of the device.There are also ridges and bumps under the black sheath.A review of the device history records identified no deviations or anomalies during manufacturing.Medical records were not provided.A definitive root cause cannot be determined.The event is confirmed via returned product.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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