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 02/08/2024 |
Event Type
malfunction
|
Manufacturer Narrative
|
H10: internal complaint reference: (b)(4).
|
|
Event Description
|
It was reported that during a thr surgery, the polarcup impactor part for handle broke during impaction.No piece fell inside the patient.The procedure was resumed, without any delay, using a s+n back-up device.Patient was not injured as consequence of this problem.
|
|
Manufacturer Narrative
|
It was reported that during a total hip replacement surgery, the polarcup impactor part for handle broke during impaction.No piece fell inside the patient.Patient was not injured as consequence of this problem.The complaint device was returned for investigation.A visual evaluation of the device was conducted, and it was concluded that the sample is fractured in two big pieces through the proximal notch, it cannot be confirmed that possible broken-off small pieces have all been retrieved and returned as well.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 11 additional similar complaints for the same product number over the past 12 months with similar failure mode.Corrective actions has been previously initiated to reduce the occurrence of this issue.The reported batch was produced before the implementation of the corrective action.No further escalation is required.A review of the risk management documentation verifies the failure mode, occurrence and severity of the reported issue.There is no indication that the reported device failed to meet manufacturing specifications upon release for distribution.The root cause of the reported event remains undetermined.Normal wear and tear are known to contribute to the reported event.Additionally, repeated steam sterilization processes could contribute to an embrittlement.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.The need for further actions is not indicated.Nevertheless, smith+nephew will continue to monitor this device/these devices for similar issues.The returned device will be discarded.
|
|
Search Alerts/Recalls
|
|
|