DEPUY ORTHOPAEDICS INC US QUICKSET 1PC FLEX DRILL BIT 30; DRILLS (BITS, SLEEVES, GUIDES) : DRILLS
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Model Number 2274-30-500 |
Device Problem
Scratched Material (3020)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/21/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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It was reported that when setting up the table for hip surgery, the nurse noticed the handle did not clip well to secure the instruments; drill bits were cut (probably during cleaning in mdr), outer sleeve is hard to use and put the offset part in it.
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Manufacturer Narrative
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Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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Manufacturer Narrative
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Product complaint (b)(4).Investigation summary: the device associated with this report was returned to depuy synthes for evaluation.Visual inspection of the returned sample revealed, the tip of the device broke off.The broken fragment was not returned for evaluation.The reported allegation can not be confirmed.Additional monitoring, for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A records evaluation (mre) was not performed.
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Search Alerts/Recalls
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