MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARCUP TRIAL INSERT NAV 22/55; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	75023362
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during thr surgery, a polarcup trial insert nav 22/55 broke during impaction of the cup, however all the pieces were retrieved.The device was located outside the patient at the moment of the issue.The procedure was completed using a s+n back-up device and without delay.No other complicatios were reported.
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Additional Manufacturer Narrative
It was reported that, during total hip replacement surgery, a polarcup trial insert nav 22/55 broke during impaction of the cup, however all the pieces were retrieved.The device was located outside the patient at the moment of the issue.The procedure was completed using a s+n back-up device and without delay.No other complications were reported.The device intended for use in treatment was not returned for investigation.A product evaluation was not possible.A review of the production documentation did not detect any deviation that could have contributed to the reported failure mode.The performed complaint history review for the device revealed no additional complaints reported for the batch (a52530) in scope with similar failure mode, and 4 additional complaints reported for the same product number (75023362) over the past 12 months with similar failure mode.Previous investigations demonstrated that the performance of the device is within the risks level that are anticipated in the risk management documentation.As part of the continuous improvement, smith + nephew is working on a design enhancement.A review of the risk management documentation verifies the failure mode, occurrence and severity of the reported issue.There is no objective indication that the reported devices failed to meet manufacturing specifications upon release for distribution.Based on the information provided to the complaint, it is not possible to confirm the reported failure mode.A relationship between the reported event and the device cannot be confirmed, the performed investigation do not lead to an accurately determined cause.Due to insufficient information, it is not possible to speculate about factors which could have contributed to the reported event.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.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.
Additional Manufacturer Narrative
H3, h6: it was reported that, during total hip replacement surgery, a polarcup trial insert nav 22/55 broke during impaction of the cup, however all the pieces were retrieved.The device was located outside the patient at the moment of the issue.The complaint device intended for use in treatment was returned for investigation.A visual evaluation of the returned device was conducted.It was concluded that the complaint device was fractured into 4 pieces and showed some signs of usage.A review of the production documentation did not detect any deviation that could have contributed to the reported failure mode.The performed complaint history review for the device revealed no additional complaints reported for the batch (a52530) in scope with similar failure mode, and 4 additional complaints reported for the same product number (75023362) over the past 12 months with similar failure mode.Previous investigations demonstrated that the performance of the device is within the risks level that are anticipated in the risk management documentation.As part of the continuous improvement, smith + nephew is working on a design enhancement.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 devices failed to meet manufacturing specifications upon release for distribution.The performed investigation do not lead to an accurately determined cause.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.Nevertheless, smith + nephew will continue to monitor this device for similar issues.The returned device will be discarded.

• Brand Name: POLARCUP TRIAL INSERT NAV 22/55
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: 15879756
• Report Number: 9613369-2022-00602
• Device Sequence Number: 5361859
• Product Code: LXH
• UDI-Device Identifier: 07611996112511
• UDI-Public: 07611996112511
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/20/2023

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: 75023362
• Device Catalogue Number: 75023362
• Device Lot Number: A52530
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2022
• Supplement Date Received by Manufacturer: 12/16/2022; 02/17/2023
• Initial Report FDA Received Date: 11/29/2022
• Supplement Report FDA Received Date: 12/16/2022; 02/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/13/2014
• 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
• Patient Sex: Unknown