SMITH & NEPHEW, INC. DBL OFFSET BROACH HDLE LT; PROST, HIP, FEMORAL COMPONENT, CEMENTED, METAL
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Model Number 71360089 |
Device Problem
Unstable (1667)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/09/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported that the instrument is allowing too much wiggle and is losing grip.Failure in device occurred during use, while outside the patient.A s+n backup device was used to complete the procedure.No surgical delay or injury to the patient was reported.
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Manufacturer Narrative
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Results of investigation: the associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The device has several nicks and scratches as well as wear rendering the device inoperative.The device was manufactured in 2015 and shows signs of extensive use.A function evaluation of the returned device confirmed the stated failure mode.The device allows too much wiggle and loses its grip.A review of complaint history did not reveal 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.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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