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Model Number 7209485 |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/14/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Internal complaint reference (b)(4).
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Event Description
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It was reported that, when opening the package, the loop of the "meniscus mender ii (disposable set)" fell off.It is unknown if the event happened during surgery.Therefore, no patient involvement or surgical complications could be confirmed.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
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Manufacturer Narrative
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H10 h3, h6: the reported device, intended for use in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.An analysis of the customer provided image confirmed the part and batch numbers for the device.A visual inspection found that the first meniscal loop suture was detached from the shaft itself, and the other was bent and detached from the handle.It appeared to have been removed from the packaging by pulling up on the metal shaft rather than pushing out the handle from behind the packaging.The handle was placed back in the packaging upside down.The loop contained debris indicating that it was used despite the detachment from the handle.One of the other instruments had been removed from the packaging, but did not appear to be used.A review of the device records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was a repeat issue.The complaint was confirmed and the root cause was associated with device design.
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Search Alerts/Recalls
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