Model Number 2353-3503 |
Device Problem
Failure to Align (2522)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/11/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Upon completion of the investigation any additional information will be communicated in a supplemental report.
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Event Description
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It was reported that when setting initial depth and version with the mil fal the lag screw k-wire, it kept missing the nail posterior and hit once proximal.This resulted in a 1-1.5 hour surgical delay.Pre-testing confirmation of recon lag screw targeting at a prior date and the device worked as expected.Another surgeon scrubbed in and assisted the lost reduction of the fracture and helped complete the case.
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Manufacturer Narrative
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The reported event could not be confirmed, since the returned device is conforming to specifications and fully functional.A simulation of a pre-surgical function check revealed function is given as intended.According to event description ¿not prior to nail insertion but pre-testing confirmation of recon lag screw targeting was performed at a prior date and it worked fine¿.Based on above facts the case is rather related to a sub-optimal intraoperative procedure and has to be classified as user related.A review of the inspection records for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.In case substantive information will become available in future that suggests otherwise we reserve the right to reopen the case.
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Event Description
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It was reported that when setting initial depth and version with the mil fal the lag screw k-wire, it kept missing the nail posterior and hit once proximal.This resulted in a 1-1.5 hour surgical delay.Pre-testing confirmation of recon lag screw targeting at a prior date and the device worked as expected.Another surgeon scrubbed in and assisted the lost reduction of the fracture and helped complete the case.
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Search Alerts/Recalls
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