Catalog Number 519650 |
Device Problem
Loose or Intermittent Connection (1371)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/27/2024 |
Event Type
malfunction
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Event Description
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According to the available information the device would not maintain its tensioning.
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Event Description
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Additional information received on 3/6/2025 indicates the following: reportedly, the tensioning suture felt like it was "greased" and would not hold tension.A second sling was placed successfully.
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Manufacturer Narrative
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An altis sling was received for evaluation.Examination of the sling revealed no functional abnormalities.The dynamic and static anchors were still attached.Blood residue was noted on the sling.Based on examination of the returned product no functional anomalies were noted with the sling or anchors.The information received indicated when the physician went to tension the sling, it wasn't holding.The tensioning suture felt like it was "greased" and wouldn't hold tension.A second sling was placed successfully.A review of the device history record by the contract manufacturer confirmed the devices from this lot met all specifications prior to release.A review of the complaint history database, nonconformances and capas revealed no trends for this lot.
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Event Description
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Additional information received on 3/6/2025 indicates the following: reportedly, the tensioning suture felt like it was "greased" and would not hold tension.A second sling was placed successfully.
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Search Alerts/Recalls
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