SMITH & NEPHEW, INC. JOURNEY DCF AP FEM CUT BLK 5; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
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Model Number 74012415 |
Device Problem
Break (1069)
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Patient Problems
No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/26/2020 |
Event Type
malfunction
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Event Description
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It was reported that during efip inspection the rods of the journey dcf ap fem cut blk 5 were found to be broken.No case related, therefore no patient involved.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 device, intended for use in treatment was returned for evaluation.Visual inspection of the returned device is broken and confirms that the device has signs of wear and tear from use.The device was manufactured in 2008.A review of the manufacturing records did not reveal any manufacturing or material abnormalities that could have caused or contributed to the reported incident.A review of complaint history for the listed part revealed no prior complaints at this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.The device is a reusable device that can be exposed to numerous surgeries and cleaning cycles.Probable causes that could contribute to the reported event, as reusable instruments are susceptible to damage from prolonged use and through misuse or rough handling.To avoid compromised performance or damage, it is recommended the device be inspected prior to and after each use and cleaning.We recommend that all re-usable instruments be routinely inspected for wear/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 actions are being taken at this time.We consider this investigation closed.Credit will be issued for the device.
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Search Alerts/Recalls
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