SMITH & NEPHEW, INC. R3 VARIABLE ANGLE DRILL GUIDE; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
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Model Number 71364477 |
Device Problems
Break (1069); Component Missing (2306)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/16/2021 |
Event Type
malfunction
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Event Description
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It was reported that, after a thr surgery, an r3 variable angle drill guide broke and the pin that retracts the adjustability of the guide was missing.Surgery had been completed, without any delay, with the same device but a smith & nephew backup device was available.Patient was not harmed as consequence of this problem.
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Manufacturer Narrative
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H6: the device, intended for use in treatment was returned for evaluation: a visual inspection was conducted and confirmed the r3 variable angle drill guide broke and the pin that retracts the adjustability of the guide was missing.A review of complaint history revealed additional complaints for the listed batch.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.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.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.
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