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Model Number VLOCM3225 |
Device Problems
Break (1069); Dull, Blunt (2407); Material Twisted/Bent (2981)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/17/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Medtronic conducted an investigation based upon all information received.Only the packaging of the product was returned.Visual inspection of the returned packaging noted an open foil pouch and retainer.It was reported that the suture thread broke, the device had bent out of its intended shape, and the tip of the needle was blunt or dull.The reported issues could not be confirmed.The most likely cause could not be established from the information available.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.A secondary review of the device history records found no potentially contributing factors.If information is provided in the future, a supplemental report will be issued.
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Event Description
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According to the reporter, after the second pass when closing an open total knee revision, the needle bent and became dull then the suture broke.The malfunction happened twice.A new suture was used.There was no patient injury.
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Search Alerts/Recalls
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