MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 3.5MM LOCKING HEX T-HANDLE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	74016422
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).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 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 an uka surgery, the screw of one (1) rm/ll tibia resection guide standard could no longer be adjusted, and more force was applied causing one (1) 3.5mm locking hex t-handle to break.No parts fell into the patient.The procedure was resumed without delay using the same devices, and no injuries were reported as a result.
Additional Manufacturer Narrative
This complaint has been reassessed based on the information made available to the manufacturer.It was determined that this event does not fulfill reporting requirements per 21cfr803.No serious injury to the patient/user occurred or might have occurred as a consequence of the reported issue.The subject device broke off while the screw of the tibia cutting guide was manipulated in the instrument table.As a result, there is no risk of broken pieces entering the patient incision.In addition, the screw in question is typically adjusted while the device is placed external to the patient's incision during an uka procedure.This complaint will be monitored as part of our established post-market surveillance process.

• Brand Name: 3.5MM LOCKING HEX T-HANDLE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 21702228
• Report Number: 1020279-2025-00554
• Device Sequence Number: 8664327
• Product Code: LXH
• UDI-Device Identifier: 00885556692240
• UDI-Public: 885556692240
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2025

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: 74016422
• Device Lot Number: 22JSC0001
• 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: 03/10/2025
• Supplement Date Received by Manufacturer: 04/25/2025
• Initial Report FDA Received Date: 03/26/2025
• Supplement Report FDA Received Date: 04/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/16/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: RM/LL TIBIA RSCTN GUIDE STRD (74036107, 21HPG0008)
• Patient Sex: Unknown