MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARCUP REDUCER PART FOR IMPACTOR

Catalog Number	75023344
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during a thr, the head pusher tip of one (1) polarcup reducer part for impactor broke in half while impacting the femoral head.One piece fell on the floor and the other fell into the incision and was retrieved by hand.The procedure was resumed, without any delay, using a s+n back-up device.Patient was not harmed as a consequence of this problem.
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Additional Manufacturer Narrative
Section h3, h6: it was reported that, during a total hip replacement, the head pusher tip of one (1) polarcup reducer part for impactor broke in half while impacting the femoral head.One piece fell on the floor and the other fell into the incision and was retrieved by hand.Patient was not harmed as a consequence of this problem.The device intended for use in treatment was not returned for investigation.A visual evaluation was performed on images provided by the complainant, and it showed a fracture across the middle through the proximal notch.The device appears to be covered in blood and shows signs of usage such as superficial scratches.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 1 additional similar complaints reported for the same batch, and 2 additional similar complaints for the same product number over the past 12 months with similar failure mode.Review of past corrective actions was performed.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.The root cause of the event can be attributed to a known inherent risk of the device.There is no indication that the reported devices failed to meet manufacturing specifications upon release for distribution.Considering the performed visual inspection, it is suspected that the mentioned device failure arose from a ¿wear and tear" issue.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.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.

• Brand Name: POLARCUP REDUCER PART FOR IMPACTOR
• Common Device Name: IMPACTOR
• 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: 18956618
• Report Number: 9613369-2024-00028
• Device Sequence Number: 4500646
• Product Code: HWA
• UDI-Device Identifier: 07611996112337
• UDI-Public: 07611996112337
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2024

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 Catalogue Number: 75023344
• Device Lot Number: A77811
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2024
• Supplement Date Received by Manufacturer: 04/24/2024
• Initial Report FDA Received Date: 03/21/2024
• Supplement Report FDA Received Date: 04/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/13/2012
• 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