Catalog Number 228734000 |
Device Problems
Difficult to Remove (1528); Connection Problem (2900); Device-Device Incompatibility (2919); Material Deformation (2976); Naturally Worn (2988)
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Patient Problem
Not Applicable (3189)
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Event Date 03/01/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Product complaint # (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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Once the instruments were opened the nurse was asked to check to make sure the drill and rod fit through the central hole, it was found that it did not fit through the std + a/p resection block but did fit through the other sizes.
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Manufacturer Narrative
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B)(4).Investigation summary = > examination of the returned device(s) confirms the reported event.Product problem has not been identified.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.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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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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Search Alerts/Recalls
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