Catalog Number 110029136 |
Device Problem
Dull, Blunt (2407)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/03/2024 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).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 while the surgeon was using the instrument, the instrument was very dull and hardly cut through bone.A second instrument was used to complete the procedure.There was no report of harm to the patient.
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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional and corrected information.The following sections were updated: b4; b5; d2; g2; g3; g6; h1; h2; h4.The following section was corrected: d1; d4: lot number.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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No further event information available at the time of this report.
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Search Alerts/Recalls
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