MAUDE Adverse Event Report: ARTHREX, INC. HANDLE, QC, RATCHETING, CANNULATED; MANUAL INSTR, GENERAL SURGICAL

Model Number	HANDLE, QC, RATCHETING, CANNULATED
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 10/14/2025, it was reported by a facility representative via (b)(4) that an ar-8950rh ratcheting handle stopped ratcheting during a case, causing the doctor to over-torque a screw.Happened during a case and was completed successfully with no patient effect.
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 the complaint device was not received for evaluation.Based on the provided information, which may include the device (if available and returned), pictures, videos, event descriptions, and any additional field data, arthrex concluded that the most likely cause of the reported failure was wear and tear of the device.The device was manufactured in 2016.Since the complaint device was not returned and no evidence of the failure was provided, neither physical inspection nor a review of images could be performed.As a result, the complaint allegation could not be confirmed.

• Brand Name: HANDLE, QC, RATCHETING, CANNULATED
• Common Device Name: MANUAL INSTR, GENERAL SURGICAL
• 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: 23336463
• Report Number: 1220246-2025-04695
• Device Sequence Number: 21218570
• Product Code: LXH
• UDI-Device Identifier: 00888867133259
• UDI-Public: (01)00888867133259(11)160303(10)78421609
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2026

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: HANDLE, QC, RATCHETING, CANNULATED
• Device Catalogue Number: AR-8950RH
• Device Lot Number: 78421609
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2025
• Supplement Date Received by Manufacturer: 02/18/2026
• Initial Report FDA Received Date: 10/20/2025
• Supplement Report FDA Received Date: 02/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/03/2016
• 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