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
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2022
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional Manufacturer Narrative
Internal complaint reference: case-(b)(4).
Additional 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
• Common Device Name: 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
• Report Number: 9613369-2022-00040
• Device Sequence Number: 5075987
• Product Code: KWY
• UDI-Device Identifier: 07611996112351
• UDI-Public: 07611996112351
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K110135
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: 75023346
• Device Catalogue Number: 75023346
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2022
• Supplement Date Received by Manufacturer: 04/19/2022
• Initial Report FDA Received Date: 03/01/2022
• Supplement Report FDA Received Date: 04/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown