SMITH & NEPHEW, INC. MI Z HANDLE ACET REAMER; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
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Model Number 71364073 |
Device Problem
Mechanical Problem (1384)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/04/2021 |
Event Type
malfunction
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Event Description
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It was reported that during set up for tha surgery the mi z handle acet reamer was having issues properly assembling and disassembling.Sleeves were extremely difficult to remove.The procedure was completed, without delay, using the same device.No patient injuries and no other complications were reported.
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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 does not confirm the stated failure mode.The device shows signs of extensive use.A functional evaluation of the returned device confirm the stated failure mode.The device functions as necessary, but difficult to assemble and disassemble as stated.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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