Model Number 1307-61-138 |
Device Problems
Difficult to Insert (1316); Device Damaged Prior to Use (2284)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/09/2021 |
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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Surgeon had trouble getting glenosphere implant (1307-61-138) to engage in metaglene.He tried to get the implant seated and thread down the screw but it wouldn't engage.Eventually he pulled out the implant and found the threads had been damaged.He ended up implanting the original glenosphere version (1307-60-138) and suggested that the longer threads on that version may have helped it to engage.This was very similar to what happened in the last reverse shoulder case he did.He suggested also that the shoulder was very small and difficult to expose.See (b)(4).
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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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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary = > examination of the returned device found could confirm the reported allegation.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 = > has reviewed the device history record (dhr) review was conducted by the manufacturing site for the finished device 130761138, lot number d21052475, it was manufactured on 23-may-2021.(b)(4) parts were manufactured per specification and all raw materials met specification, and no non-conformances were identified.
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Search Alerts/Recalls
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