SMITH & NEPHEW, INC. ORTHOMATCH CR IMPLANT IMPACTOR; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED,
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Catalog Number 71436399 |
Device Problem
Material Separation (1562)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 04/14/2020 |
Event Type
malfunction
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Event Description
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It was reported that, during an unspecified surgery, the impactor broke down, outside the patient.The fragments of the device did not fall into the patient's body.An s&n backup device was available to complete the procedure with no delay.The patient was not injured: the surgery ended well for him.
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Manufacturer Narrative
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The device, used in treatment, was returned for evaluation.A visual inspection confirmed the orthomatch cr implant impactor is broken into three pieces.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.
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Search Alerts/Recalls
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