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Model Number FLX REAMER & TIGHTROPE DRILL PIN 10.0MM |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/26/2023 |
Event Type
malfunction
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Manufacturer Narrative
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The contribution of the device to the reported event has not yet been determined as the device has not been returned for evaluation at this time.A follow-up report will be submitted, including a most likely cause if a root cause can not be determined.
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Event Description
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On 05/26/2023, it was reported by a sales representative via sems that an ar-1401f-100 flexible reamer with flexible tightropes reamer was having difficulty advancing thru the cortex.The reamer then broke midway up the shaft.This occurred during an acl reconstruction on (b)(6)2023, when trying to ream a femoral tunnel the reamer was having difficulty advancing thru the cortex.The reamer then broke midway up the shaft.The doctor retrieved the reamer out over the guide pin.They then used a low-profile reamer over the flexible pin to complete the socket and everything ended fine.There was no harm to the patient.
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Search Alerts/Recalls
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