MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARCUP TRIAL INSERT SLOTTED 28/49; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	75000665
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference (b)(4).H11.H3, h6: this complaint was opened by smith+nephew to document a product problem associated with a smith+nephew device.The reported problem relates to known inherent device and/or procedural risks that are appropriately documented in our risk files.Smith+nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.Smith+nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture.Based on our review of all currently available information, we are unable to identify a definitive root cause.However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations.If additional investigative findings or information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.
Event or Problem Description
It was reported that, during a thr surgery, one (1) polarcup trial insert slotted 28/49 broke in half while trial reducing.It is unknown if there was any surgical delay.Also, it is unknown how the procedure was finished.No injury was reported as a consequence of this issue.
Additional Manufacturer Narrative
The complaint device intended for use in treatment was not returned for investigation.A product evaluation was not possible.No batch number was communicated so the production history review was not possible.Due to an unknown batch number, the review of historical complaints was performed on product number basis only, revealing 2 additional complaints 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.No further escalation is required.A review of the risk management documentation verifies the failure mode, occurrence and severity of the reported issue.The performed investigation does not lead to an accurately determined cause.Based on the available information it is not possible to investigate whether the reported device met manufacturing specifications upon release for distribution.This device is a reusable instrument that can be exposed to numerous surgeries.Damage from repeated resterilization, prolonged use, misuse or rough handling are likely potential factors that could contribute to the reported event.Therefore, all reusable instruments must be routinely inspected for signs of wear and damage after reprocessing.Any instruments found to be damaged should be replaced as necessary to ensure their proper functioning and to maintain patient safety.This guidance is provided by smith & nephew orthopaedics ag (reference: lit.N°03389-en 1363 v4 01/25).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 TRIAL INSERT SLOTTED 28/49
• 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 ; 1450 brooks rd.; memphis, TN 38116 ; 5123913905
• MDR Report Key: 22861601
• Report Number: 9613369-2025-00119
• Device Sequence Number: 7632248
• Product Code: LXH
• UDI-Device Identifier: 07611996116793
• UDI-Public: 07611996116793
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K110135
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 09/09/2025

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: 75000665
• Device Lot Number: UNKNOWN
• 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: 07/31/2025
• Supplement Date Received by Manufacturer: 09/04/2025
• Initial Report FDA Received Date: 08/21/2025
• Supplement Report FDA Received Date: 09/09/2025
• 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