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

Model Number	JIG, PARS
Medical Device Problem Codes	Positioning Failure (1158); Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/23/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2025, it was reported by a sales representative via (b)(4) that an ar-8860j jig, pars central tongs of the jig were deviating/jiggling and were unable to be tightened or adjusted to prevent this.The surgeon attempted to manipulate the jig and adjust the knobs/screws/dials that the pars jig has to prevent the tongs/arms from moving, but this did not fix the issue.The surgeon had to open the procedure and bail out to a different plan.In order to complete the procedure, the surgeon opened the incision further and used krakow stitches to bring the achilles tendon together.This was discovered during a pars achilles rupture repair.The case was complete with no patient harm.
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.Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to user error.When inserting the ar-8860j pars instrument into the transverse incision, the tines should be on the closed position to prevent damage to the tendon as well as limit movement of the tines upon insertion; ref: pars achilles midsubstance speedbridge¿ implant system - 06/18/2020 surgical technique vid1-001046-en-us a.Ref: pars achilles midsubstance speedbridge¿ implant system _ surgical technique guide lt1-000289-en-us d.

• 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: 22781730
• Report Number: 1220246-2025-03425
• Device Sequence Number: 15517975
• Product Code: LXH
• UDI-Device Identifier: 00888867048621
• UDI-Public: (01)00888867048621(11)230222(10)012308
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: JIG, PARS
• Device Catalogue Number: AR-8860J
• Device Lot Number: 012308
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2025
• Supplement Date Received by Manufacturer: 12/07/2025
• Initial Report FDA Received Date: 08/12/2025
• Supplement Report FDA Received Date: 12/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/22/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown