SMITH & NEPHEW, INC. JOURNEY DCF AP FEM CUT BLK 7; PRSTHSS,KNEE,FEMOROTIBIAL,SEMI-CONSTRAINED,CMNTD,MTL/POLYMER
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Model Number 74012417 |
Device Problem
Break (1069)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/16/2020 |
Event Type
malfunction
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Event Description
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It was reported that when inspecting the cutting block in the sterile processing department that the metal where the slap hammer attaches to the block has either been worn off or broken off over time of usage.This was discovered when trays were being put back together, not in surgery.And it is unknown when this exactly occurred or if anything from the block ever made it into a patient.
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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 performed and confirmed the device appears the metal where the slap hammer attaches to the block is excessively worn.The manufactured date for this device is 2015.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.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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