WRIGHTS LANE SYNTHES USA PRODUCTS LLC 7 TI MULTILOC HUMERAL NAIL RT/CANN/240-S; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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Model Number 04.016.240S |
Device Problems
Device-Device Incompatibility (2919); Material Twisted/Bent (2981)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/23/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Additional narrative: complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed; no conclusion could be drawn, as no product was received.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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Event Description
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It was reported that on (b)(6) 2021, patient underwent a surgical procedure, while inserting an interlocking multliloc screw, the screw was too short.The surgeon continued to try to insert the multiloc screw possible stripping out the plastic insert of the multiloc humeral nail.The screw was pulled out of the bone and nail, and abandoned that screw hole procedure was completed successfully with a five(5) minutes surgical delay.No patient consequence reported.Concomitant device reported: unk - insertion instruments: trauma (part# unknown; lot# unknown; quantity: 1).This report is for one (1) 7 ti multiloc humeral nail rt/cann/240-s.This is report 1 of 2 for complaint (b)(4).
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Search Alerts/Recalls
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