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

Model Number	75000657
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Smith & nephew is submitting this report pursuant to the provisions of 21 c.F.R.Part 803.This report may be based upon information which smith & nephew has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, smith & nephew, or its employees, that the report constitutes an admission that the device, smith & nephew or its employees caused or contributed to the potential event described in this report.(b)(4).
Event or Problem Description
It was reported that during thr, a part of the back lip of one (1) polarcup trial insert slotted 22/55 broke while placing the trials into the patient.The procedure was resumed, without any delay, using a s+n back-up device.Patient was not injured as consequence of this problem.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Event or Problem Description
It was reported that during thr, a part of the back lip of one (1) polarcup trial insert nav 22/55 broke while placing the trials into the patient.The procedure was resumed, without any delay, using a s+n back-up device.Patient was not injured as consequence of this problem.
Additional Manufacturer Narrative
H3, h6: it was reported that during total hip replacement, a part of the back lip of one (1) polarcup trial insert slotted 22/55 broke while placing the trials into the patient.The device intended for use in treatment was returned for investigation.The product was returned completely.Upon visual inspection, the reported failure mode could be confirmed, as 2 pieces at the distal tips were broken off.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 complaint device revealed no previous complaints for the same batch, and a review for the part number over the past 12 months in scope with similar failure mode revealed 3 similar events.Previous investigations demonstrated that the performance of the device is within the risk levels that are anticipated in the risk management documentation.As part of the continuous improvement, smith + nephew is working on a design enhancement.No further escalation is required.A review of the risk management documentation verifies the failure mode, occurrence and severity of the reported issue.Based on the performed investigations, the relationship between the reported event and the device was confirmed, and the root cause stays undetermined after investigation.Normal wear and tear are known to contribute to the reported event.Additionally, repeated steam sterilization processes could contribute to an embrittlement.To date, further actions are not deemed necessary.There is no objective indication that the reported devices failed to meet manufacturing specifications upon release for distribution.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.The need for corrective action is not indicated.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: 15788810
• Report Number: 9613369-2022-00591
• Device Sequence Number: 5298591
• Product Code: LXH
• UDI-Device Identifier: 07611996112511
• UDI-Public: 07611996112511
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/02/2023
• 2 Devices were Involved in the Event: 1 2

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: 75000657
• Device Catalogue Number: 75023362
• Device Lot Number: B69366
• 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: 10/20/2022
• Supplement Date Received by Manufacturer: 11/22/2022; 12/30/2022
• Initial Report FDA Received Date: 11/14/2022
• Supplement Report FDA Received Date: 12/01/2022; 01/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/16/2019
• 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