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Model Number FLEXIBLE REAMER SHAFT, Ø2.0MM |
Device Problems
Break (1069); Defective Device (2588); Noise, Audible (3273); Separation Problem (4043)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/26/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
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Event Description
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On (b)(6) 2021, it was reported by a sales representative via e-mail that the 0222-200 was found defective and unusable.No case involvement.Additional information provided 8/27/2021: started flex reamer from aos humeral nail set at 6.5mm through a 10.5mm entry hole down the humeral canal.Surgeon immediately noticed a ¿chatter¿ sound which then sized up reamers by.5mm until they reached 8.Throughout upsized reaming, surgeon noticed the same ¿chatter" sound.Halfway down humeral canal, flex reamer broke and revealed a faulty flex reamer base which had separated from the flex shaft leaving ao connect in drill hand piece.The case was completed by using an aos tibia/femoral flex reamers set.
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Search Alerts/Recalls
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