DEPUY ORTHOPAEDICS INC US PIN REV DOME DRILL 25MM; DRILLS (BITS, SLEEVES, GUIDES) : DRILLS
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Catalog Number 227425800 |
Device Problems
Break (1069); Entrapment of Device (1212); Fracture (1260)
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Patient Problem
No Code Available (3191)
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Event Date 09/24/2019 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).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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During hip revision surgery today approx 18mm of the pinnacle dome drill bit broke off during use.It wasn¿t possible to remove the broken piece which remained in the patient.There was a few minutes delay as a result of the breakage.
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Manufacturer Narrative
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Depuy synthes is submitting this report pursuant to the provision depuy synthesof 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.Additional narrative: product complaint # (b)(4).Investigation summary no device was received.Root cause undetermined.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 null.Device history batch null.Device history review null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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Additional information received that there was a few minutes delay as a result of the breakage.
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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. additional narrative: added: event.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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Search Alerts/Recalls
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