WRIGHTS LANE SYNTHES USA PRODUCTS LLC HELICAL BLADE/SCREW EXTRACTOR; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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Catalog Number 03.037.030 |
Device Problem
Material Twisted/Bent (2981)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/31/2022 |
Event Type
malfunction
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Event Description
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Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6), 2022, the surgeon indicated that the threads on two tfna extraction instruments were stripped and needed to be replaced.The instruments in question are the nail extractor and the screw/blade extractor.There were no patient consequences.This report involves one (1) helical blade/screw extractor.This is report 2 of 2 for (b)(4).
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Manufacturer Narrative
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Additional narrative: complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.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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Search Alerts/Recalls
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