SMITH & NEPHEW, INC. R3 LNR MPACTOR HD II 38-42MM; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
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Model Number 71366438 |
Device Problems
Crack (1135); Naturally Worn (2988); Scratched Material (3020)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/25/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Internal reference number case (b)(4).
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Event Description
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It was reported that a r3 liner impactor head were scratched, cracked and worn.As this was noticed upon inspection, there was not patient involvement.
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Manufacturer Narrative
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H3, h6: the device, intended for use in treatment was returned for evaluation: a visual inspection was conducted and confirmed that the r3 lnr mpactor hd ii 38-42mm is damaged.The device is scratched, cracked, and worn which causes it to not properly function.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.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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