SMITH & NEPHEW, INC. TRIGEN EXT FLEXIBLE REAMER SHAFT 65CM; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
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Model Number 71935419 |
Device Problem
Crack (1135)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/21/2020 |
Event Type
malfunction
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Event Description
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It was reported that, a trigen ext flexible reamer shaft 65cm was seen to be cracked.Incident occurred during inspection.No case reported; therefore, there was no patient involvement.
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Manufacturer Narrative
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The associated device, intended for use in treatment, was returned and evaluated.A visual inspection of the returned device could confirm the stated failure mode.The tip of the device is cracked, rendering the device inoperable.The device shows signs of extensive.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history did not reveal additional complaints for the listed batch.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.This device is a reusable instrument that can be exposed to numerous surgeries.Damage from prolonged use, misuse or rough handling are likely probable causes of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.
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