SMITH & NEPHEW ORTHOPAEDICS AG POLARCUP IMPACTOR PART FOR HANDLE; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED
|
Back to Search Results |
|
Catalog Number 75023346 |
Device Problem
Fracture (1260)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 10/23/2023 |
Event Type
malfunction
|
Event Description
|
It was reported that, during a thr surgery, a polarcup impactor part for handle broke while impacting cup in position.The procedure was resumed, without any delay, using the same device.No injury was reported as a consequence of this issue.
|
|
Manufacturer Narrative
|
Internal complaint reference: (b)(4).
|
|
Manufacturer Narrative
|
It was reported that, during a total hip replacement surgery, a polarcup impactor part for handle broke while impacting cup in position.The procedure was resumed, without any delay, using the same device.The device used in treatment was not returned for investigation.A product evaluation was not possible.A review of the production documentation did not detect any deviation that could have contributed to the reported failure mode.The review of historical complaints for the alleged device revealed no additional similar complaints reported for the same batch, and 8 additional similar complaints for the same product number over the past 12 months with similar failure mode.Due to insufficient information it is not possible to perform a review of past corrective actions.A review of the risk management documentation verifies the failure mode, occurrence and severity of the reported issue.The performed investigation does not lead to an accurately determined cause.There is no indication that the reported device failed to meet manufacturing specifications upon release for distribution.Due to insufficient information, it is not possible to indicate factors which could have contributed to the reported event.According to document "processing (cleaning, disinfection and sterilization) of instruments from smith & nephew orthopaedics ag" (lit.N°03389-en 1363 v3 11/19), all devices must be inspected and controlled for proper functioning after cleaning/disinfection.There is no need for further actions because of the limited information provided.Nevertheless, smith + nephew will continue to monitor this device for similar issues.This complaint will be reopened should additional information or the device be received.
|
|
Search Alerts/Recalls
|
|
|