SMITH & NEPHEW, INC. GII P/S CONS HOUSING REAM DOME; PRSTHSS, KN, PTLL/FMRTBL, SM-CNSTRND, NCMNTD, PRS, CTD, PLYMR/MTL/PLYMR
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Model Number 71440145 |
Device Problem
Material Integrity Problem (2978)
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Patient Problem
No Patient Involvement (2645)
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Event Date 06/01/2020 |
Event Type
malfunction
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Event Description
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It was reported that the device was found wear and tear.No injury reported.No case involved.
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Manufacturer Narrative
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The device, used in treatment, was returned for evaluation.A visual inspection confirmed the gii p/s cons housing ream dome shows nicks and scratches.The device shows significant signs of wear/usage.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 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.We consider this investigation closed.
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Manufacturer Narrative
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Additional information received by the manufacturer has identified that this event should be re-evaluated for mdr reporting.The new information states that the device malfunction doesn't require a medical intervention to be treated in the past nor in the current reported case, therefore, it was determined that this case does not meet the threshold for reporting and is a non-reportable event.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.
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