MAUDE Adverse Event Report: ARTHREX, INC. JIG, PARS; ORTHOPEDIC MANUAL SURG INSTR

Model Number	JIG, PARS
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2025
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 08/05/2025, it was reported by an arthrex subsidiary employee via (b)(4) 1that an ar-8860j jig was used in surgery for an achilles tendon rupture.After insertion into the body, interference with the device occurred when inserting the passing needle.An attempt was made to pass the needle by changing the hand, but it ended up outside the window frame on the other side.Once the device was removed from the body and checked, it was noted that the middle window through which the needle passes was not parallel.As the nut was tightened, misalignment occurred, and since it maintained parallelism when fully opened, the needle was passed in that state.After several repeated misalignments, tape passing into the achilles tendon was completed.When the device was checked after surgery, rattle was found on only one side of the device's middle window.This occurred during use in a case with no patient effect.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.One unpackaged ar-8860j measure guide, batch 012445, was received for investigation.Upon visual inspection, it was observed that the device exhibited discoloration and surface damage.The threads also appeared to be stripped.Functional testing indicated that the device opens and closes with resistance.The most likely cause of the reported failure is wear and tear resulting from repeated use.Repeated adjustments during use may have contributed to the misalignment.Complaint allegation is confirmed.Refer to the investigation photos.

• Brand Name: JIG, PARS
• 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: 22852494
• Report Number: 1220246-2025-03562
• Device Sequence Number: 18235924
• Product Code: LXH
• UDI-Device Identifier: 00888867048621
• UDI-Public: 00888867048621
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2025

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: JIG, PARS
• Device Catalogue Number: AR-8860J
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2025
• Supplement Date Received by Manufacturer: 12/04/2025
• Initial Report FDA Received Date: 08/20/2025
• Supplement Report FDA Received Date: 12/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown