WRIGHTS LANE SYNTHES USA PRODUCTS LLC COMPLETE OPENING DRILL BIT/ REAMER ASSEMBLY; INSTR,SURGICAL,ORTHOPEDIC,AC- POWERED MOTOR/ACCESS & ATTACH
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Model Number 03.168.004 |
Device Problem
Improper or Incorrect Procedure or Method (2017)
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Patient Problem
Injury (2348)
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Event Date 01/01/2020 |
Event Type
Injury
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Manufacturer Narrative
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Only event year is known.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 an unknown date, during femoral neck system (fns) procedure the surgeon penetrated the femoral head with the triple reamer.The surgeon measured it with 87mm and set the reamer to 80mm and the reamer still penetrated to the head.The triple reamer was advanced farther into femoral head than intended and possibility exists.The reamer was possibly set to a length that was too long but that was not confirmed and did not occur at the time of the procedure.According to the surgeon, patient is pain free and wants to weight bear.The surgeon is treating the patient conservatively for now but plans to allow weight bearing soon.There was no surgical delay.Patient and procedure outcome were unknown.Concomitant device reported: bolt for femoral neck system 90mm length-sterile (part number 04.168.290s, lot unknown, quantity 1), direct measuring device for 3.2mm guide wires (part number 03.168.003, lot unknown, quantity 1).This report involves 1 complete opening drill bit/ reamer assembly.This is report 1 of 2 for (b)(4).
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