MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARCUP TRIAL INSERT NAV 22/61; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	75023365
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal reference number: (b)(4).H10: 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.
Event or Problem Description
It was reported that, during a thr, (b)(4) polarcup trial insert nav 22/61 broke during trials.It is unknown how the procedure was completed and whether there was any delay.However, patient was not harmed as a consequence of this issue.
Additional Manufacturer Narrative
H3, h6: it was reported that, during a total hip replacement (thr), one (1) polarcup trial insert nav 22/61 broke during trials.It is unknown how the procedure was completed and whether there was any delay.However, patient was not harmed as a consequence of this issue.The device, intended for use in treatment, was not returned for evaluation.Hence, no visual inspection could be performed.The review of historical complaints for the alleged device revealed one additional similar complaint reported for the same batch, and one additional similar complaint for the same product number over the past 12 months with similar failure mode.A review of the product documentation did not detect any deviation that could have contributed to the reported failure mode.Previous investigations demonstrated that the performance of the device is within the risks level that are anticipated in the risk management documentation.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 available information and the performed investigation, 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.Should the device or additional information be received, the complaint will be reopened.Smith and nephew will continue to monitor this device for similar issues.This investigation is considered closed.

• Brand Name: POLARCUP TRIAL INSERT NAV 22/61
• 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: 18681547
• Report Number: 9613369-2024-00008
• Device Sequence Number: 6194964
• Product Code: LXH
• UDI-Device Identifier: 07611996112542
• UDI-Public: 07611996112542
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2024

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: 75023365
• Device Lot Number: B70399
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2024
• Supplement Date Received by Manufacturer: 02/21/2024
• Initial Report FDA Received Date: 02/09/2024
• Supplement Report FDA Received Date: 02/23/2024
• Date Device Manufactured: 08/19/2019
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown