DEPUY ORTHOPAEDICS INC US HP QUICK DRILL PINS 6PK; DRILLS (BITS, SLEEVES, GUIDES) : DRILLS
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Model Number 9505-02-072 |
Device Problems
Entrapment of Device (1212); Improper or Incorrect Procedure or Method (2017)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/02/2022 |
Event Type
malfunction
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Event Description
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We did an attune revision tuesday (b)(6) 2022.I was alerted by the surgeon via text, with xray images showing a drill pin in the femoral canal.The surgeon thought that perhaps when he was shifting the conventional cut guide from lateral to medial, the medial pin must have fallen into the canal unnoticed.He elected to leave the pin in the canal once it showed on xray.
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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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Manufacturer Narrative
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Product complaint # : (b)(4).Investigation summary : the device associated with this report was not returned for analysis.Review of the photographic evidence confirmed the complaint.The drill pin was left inside the femur canal of the patient during surgery.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.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 manufacturing records evaluation (mre) was not performed.
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Search Alerts/Recalls
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