WRIGHTS LANE SYNTHES USA PRODUCTS LLC 13.0MM CANNULATED DRILL BIT 300MM; INSTR,SURGICAL,ORTHOPEDIC,AC-POWERED MOTOR/ACCESS & ATTACH
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Model Number 351.27 |
Device Problem
Overheating of Device (1437)
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Patient Problem
Burn(s) (1757)
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Event Date 02/20/2020 |
Event Type
Injury
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Manufacturer Narrative
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Additional device product codes gfa, gff, hsz.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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Event Description
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It was reported that on (b)(6) 2020, during femur nail using expert retrograde/antegrade femoral nail (rafn) instruments.The surgeon kept pushing the drill bit and it heated up the protection sleeve and burned the skin.Both instruments were functioning normally and have been used since the procedure.There was no surgical delay reported.The procedure was successfully completed.Patient outcome bone fixation proceeded as planned, but the patient had skin burn which was treated and healed as planned.Concomitant devices reported: 13mm protection sleeve-short (part number 03.010.229, lot unknown, quantity 1).This report involves one (1) 13.0mm cannulated drill bit 300mm.This is report 1 of 2 for (b)(4).
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Search Alerts/Recalls
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