MAUDE Adverse Event Report: ARTHREX, INC. TORQ LIMIT HANDLE, 0.8NM, QC; ORTHOPEDIC MANUAL SURG INSTR

Model Number	TORQ LIMIT HANDLE, 0.8NM, QC
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 05/16/2025, a facility representative reported via (b)(4) that an ar-8916tl-011 torque-limiting handle wouldn¿t release the driver.A case was involved, and no patient was harmed.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.One unpackaged ar-8916tl-011, torque limiting handle, batch: 672109, was received for investigation.Visual evaluation noted wear and tear along the distal end of the device: surface damage and oxidation.Functional testing noted that the device was broken/damaged -the driver shaft was loose and could be easily pulled out.The most likely cause of the reported failure can be attributed to wear and tear.The manufacturing date was 2021.The complaint allegation is confirmed.

• Brand Name: TORQ LIMIT HANDLE, 0.8NM, QC
• Common Device Name: ORTHOPEDIC MANUAL SURG INSTR
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: jared engle ; 8009337001
• MDR Report Key: 22151122
• Report Number: 1220246-2025-02394
• Device Sequence Number: 7812274
• Product Code: LXH
• UDI-Device Identifier: 00888867273924
• UDI-Public: (01)00888867273924(11)210924(10)672109
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2025

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 Model Number: TORQ LIMIT HANDLE, 0.8NM, QC
• Device Catalogue Number: AR-8916TL-011
• Device Lot Number: 672109
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2025
• Supplement Date Received by Manufacturer: 08/26/2025
• Initial Report FDA Received Date: 06/05/2025
• Supplement Report FDA Received Date: 08/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/24/2021
• 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