SMITH & NEPHEW, INC. JOURNEY DCF AP FEM CUT BLK 6; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
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Model Number 74012416 |
Device Problem
Break (1069)
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Patient Problems
No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/27/2020 |
Event Type
malfunction
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Event Description
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It was reported that the cutting block has a broken peg.Device broke during use, while outside the patient.No pieces fell inside the patient and all pieces were recovered.The procedure was completed using the same device.No delay or injury to the patient was reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
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Manufacturer Narrative
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The associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The attachment post on the device is fractured off and the fractured piece was not returned, rendering the device inoperable.The device was manufactured in 2006 and shows signs of extensive use.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history did not reveal additional complaints for the listed batch.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.This device is a reusable instrument that can be exposed to numerous surgeries.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.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 is 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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