SMITH & NEPHEW, INC. R3 OFFSET IMPACTOR TIP; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
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Model Number 71363077 |
Device Problem
Break (1069)
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Patient Problem
No Patient Involvement (2645)
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Event Date 09/04/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The device, intended use in treatment, was returned for evaluation.A visual inspection confirmed a piece is broken off the r3 offset impactor tip and has not been returned.The device shows significant signs of wear/ usage.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.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.This is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.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 warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.
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Event Description
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It was reported that during set up and inspection, the r3 offset impactor tip broke in half.No case reported; therefore, there was no patient involvement.
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