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	10/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that, a polarcup trial insert nav 22/55 and a polarcup impactor part for handle were noticed broken.As this was noticed upon cleaning and sterilization activities, there was not patient involvement.
Additional Manufacturer Narrative
Section: h3, h6: it was reported that, a polarcup trial insert nav 22/55 and a polarcup impactor part for handle were noticed broken.The complaint device, used in treatment, was returned for investigation.The reported issue could be confirmed upon visual inspection, the device was found fractured in two parts.A review of the batch record revealed no deviations from the standard manufacturing process that could have contributed to the reported issue.A review of the complaint history revealed no additional complaint for the batch in question.A review of the risk management documentation verifies the failure mode and severity of the reported issue.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.The received instrument is designed to reposition the polarcup shell.It is therefore subjected to repeated impact forces.Additionally, repeated steam sterilization processes could contribute to an embrittlement.It is however unknown for how many cycles this instrument has been used.A functional test simulating 5 years of use was performed.The observed failure could not be reproduced.Based on the conducted investigations the root cause of the fracture could therefore not be determined conclusively.There is no indication that the device failed to match specifications at the time of manufacturing.Nonetheless, in combination with our continuous effort to improve our products, design changes have been implemented to enhance the mechanical behaviour of this device.No further actions are deemed necessary at the time.Smith+nephew will continue to monitor for similar issues.The device will be retained.
Additional Manufacturer Narrative
H11.Corrected information in d3 and g1 (manufacturing site name and address).Internal reference number: (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 TN CH-50 00; SZ CH-5000
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau TN CH-50 00; SZ CH-5000
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 12829581
• Report Number: 1020279-2021-08214
• Device Sequence Number: 4364304
• Product Code: KWY
• UDI-Device Identifier: 07611996112351
• UDI-Public: 07611996112351
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K110135
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 75023346
• Device Catalogue Number: 75023346
• Device Lot Number: B61467
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2021
• Supplement Date Received by Manufacturer: 01/03/2022; 04/26/2022
• Initial Report FDA Received Date: 11/17/2021
• Supplement Report FDA Received Date: 01/05/2022; 04/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/02/2016
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown