SMITH & NEPHEW, INC. JOURNEY DCF AP FEM CUT BLK 7; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
|
Back to Search Results |
|
Model Number 74012417 |
Device Problem
Detachment of Device or Device Component (2907)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 09/09/2022 |
Event Type
malfunction
|
Event Description
|
It was reported that the screw of a journey dcf ap fem cut blk 7 came out.It is unknown when the event happened or if there was any delay nor injury reported.It is unknown if there was a s&n backup device available.Patient was not harmed.
|
|
Manufacturer Narrative
|
Internal complaint reference: (b)(4).
|
|
Manufacturer Narrative
|
H10: additional information in d4 (lot number), d9 and h4.H11: corrected information in b4 and h6 (health effect - impact code).
|
|
Event Description
|
It was reported that the screw of a journey dcf ap fem cut blk 7 came out.As the event occurred during a field inspection, there was no patient involved.
|
|
Manufacturer Narrative
|
H3, h6: the associated device was returned and evaluated.A visual inspection of the returned device confirms all the pieces that hold the spike bar to the cutting block came apart.All pieces of the device were not returned.The device shows signs of significant wear and use.A review of complaint history revealed similar events for the listed device over the previous 12 months, but no similar events for the batch based on the historical data, this failure mode will be monitored for future complaints for any necessary corrective actions.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 do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.Assessment of historical escalated cases concluded that there are no prior actions related to this device and failure mode.As the device was missing a component and it could not fit its purpose, the contribution of the device to the reported event could be corroborated.This device is a reusable instrument that can be exposed to numerous surgeries.Misassembling after reprocessing or rough handling are potential factors that may have contributed to the reported event.Additionally 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 future complaints and investigate as necessary.We consider this investigation closed.
|
|
Manufacturer Narrative
|
H3, h6: the device was not returned for evaluation and the reported event could not be confirmed.A review of complaint history of the previous 12 months revealed similar events for the listed device, this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this product and event.At this time, we have no 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 potential factors that could contribute to the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.The contribution of the device to the reported event could not be corroborated.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or 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.
|
|
Search Alerts/Recalls
|
|
|