MAUDE Adverse Event Report: ARTHREX, INC. THREADED DISTRACTOR; ORTHOPEDIC MANUAL SURG INSTR

Model Number	THREADED DISTRACTOR
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On (b)(6) 2025 it was reported by a sales representative via (b)(4) that an ar-4092 threaded distractor was broken.This was discovered during the case with no patient harm.
Additional Manufacturer Narrative
Complaint allegation is confirmed.One unpackaged ar-4092 threaded distractor was received for investigation.Visual evaluation of the returned device noted the device was significantly damaged, the device was bent, and the surface was heavily nicked, and the laser markings had been corroded off and were no longer legible.It was further noted that the device was returned stuck to an ar-4083m-20 medium oblong cutter batch: 012121 and could not be detached.Functional testing was not performed due to the damage to the device.The most likely cause for the reported failure can be attributed to user error of the device due to prying/leveraging the device during use and/or applying excessive mechanical forces.
Event or Problem Description
Upon receipt, the ar-4092 was found to be stuck inside of additional part ar-4083m-20, component of abs-4080d-m20 bio-uni disposable cutting kit.

• Brand Name: THREADED DISTRACTOR
• 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: 21251155
• Report Number: 1220246-2025-00068
• Device Sequence Number: 18203665
• Product Code: LXH
• UDI-Device Identifier: 00888867236356
• UDI-Public: 00888867236356
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 02/27/2025

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: THREADED DISTRACTOR
• Device Catalogue Number: AR-4092
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/02/2025
• Supplement Date Received by Manufacturer: 02/25/2025
• Initial Report FDA Received Date: 01/28/2025
• Supplement Report FDA Received Date: 02/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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