MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARCUP IMPACTOR PART FOR HANDLE; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED

Model Number 75023346

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/09/2022

Event Type  Injury  

Event Description

It was reported that, during a thr surgery, a polarcup impactor part for handle broke while impacting, no pieces fell inside of the patient.Surgery was resumed, without any delay, with a back-up device.Patient was not injured as consequence of this problem.

Manufacturer Narrative

Internal complaint reference: case-(b)(4).

Manufacturer Narrative

H3, h6: it was reported that, during a total hip replacement surgery, a polarcup impactor part for handle broke while impacting.The device, used in treatment, was not returned for investigation.A product evaluation could therefore not be performed.A complaint history review was performed.The occurrence of the reported failure mode is within its expected risk level as per risk management.Furthermore, the concerning risk is covered through the smith + nephew risk management file.There are no indications that the complaint device did not meet manufacturing specifications upon release for distribution.Due to insufficient information it is not possible to perform a review of past corrective actions.According to the document "processing (cleaning, disinfection and sterilization) of instruments from smith & nephew orthopaedics ag" (lit.N°03389-en 1363 v3 11/19), all instruments must be inspected and controlled for proper functioning after cleaning/disinfection.Instruments should only be used in their original condition (lit.No.12.23 ed.03/21).Based on available information, the reported failure mode could not be confirmed.A relationship between the reported event and the device cannot be confirmed.Due to insufficient information, it is not possible to speculate about factors which could have contributed to the reported event.No probable cause can be determined.The need for corrective action is not indicated.Nevertheless, smith + nephew will continue to monitor this device for similar issues.Should additional information become available, this complaint will be reopened.Internal complaint reference: (b)(4).

• Brand Name: POLARCUP IMPACTOR PART FOR HANDLE
• Type of Device: PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 13635638
• MDR Text Key: 286344411
• Report Number: 9613369-2022-00040
• Device Sequence Number: 1
• Product Code: KWY
• UDI-Device Identifier: 07611996112351
• UDI-Public: 07611996112351
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110135
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 75023346
• Device Catalogue Number: 75023346
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/09/2022
• Initial Date FDA Received: 03/01/2022
• Supplement Dates Manufacturer Received: 04/19/2022
• Supplement Dates FDA Received: 04/20/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other