DEPUY ORTHOPAEDICS INC US PIN REV DOME DRILL 25MM; DRILLS (BITS, SLEEVES, GUIDES) : DRILLS
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Model Number 2274-25-800 |
Device Problems
Device-Device Incompatibility (2919); Material Integrity Problem (2978)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/13/2022 |
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 part of drill bit that jammed into the drill guide during surgery.No surgical delay.No patient harm.
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Manufacturer Narrative
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Product complaint # (b)(4).Additional information provided "damaged instruments".Depuy synthes joint reconstruction does not consider this failure to be a reportable malfunction at this time.Further updates will only be provided if additional information is received that changes the regulatory determination.H6.
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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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Event Description
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The drill guide and drill that got jammed together.The hospital has also reported, 2 more complaints of damaged instruments.
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Search Alerts/Recalls
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