Catalog Number 130790042 |
Device Problem
Disassembly (1168)
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Patient Problem
No Information (3190)
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Event Date 07/05/2016 |
Event Type
malfunction
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Manufacturer Narrative
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This complaint is under investigation.Depuy will notify the fda of the results of the investigation once it has been completed.(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 total shoulder replacement, an inner screw was not tightened enough and came off from an outer screw when the surgeon inserted a screwdriver tip in the screw.By using a replacement, the surgery was completed with a 20-minute delay.There was no harm to the patient.
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Manufacturer Narrative
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This complaint remains under investigation.Depuy will notify the fda of the results of the investigation once it has been completed.
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Manufacturer Narrative
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The complaint description states that during total shoulder replacement, an inner screw was not tightened enough and came off from an outer screw when the surgeon inserted a screwdriver tip in the screw.The device associated to the complaint was not returned for analysis.The dhr analysis performed did not reveal any anomalies that could be related to the issue reported on the complaint.A search into the complaints database was performed, no other similar complaint was reported for the affected product code and lot combination.Based on the information received and the investigation performed, the root cause of the incident could not be determined.Depuy still 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.
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Search Alerts/Recalls
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