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

Model Number	JIG, PARS
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/30/2025
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 05/30/2025, it was reported by a sales representative via (b)(4) that an ar-8860j jig, pars alignment was off.This was discovered during the case with no patient harm.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.One unpackaged ar-8860j jig, batch number 012432 was received for investigation.Visual inspection noted wear and tear along the body: discoloration, fading, and chipping.Additionally, the threads had damage/nicks, which are all likely related to the complaint allegation.The most likely cause of the reported failure can be attributed to wear and tear, which results from excessive stress on a device that has naturally deteriorated over time due to normal usage and aging.The complaint allegation is confirmed.

• 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: 22298160
• Report Number: 1220246-2025-02594
• Device Sequence Number: 18299874
• Product Code: LXH
• UDI-Device Identifier: 00888867048621
• UDI-Public: (01)00888867048621(11)240813(10)012432
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 09/08/2025

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
• Device Lot Number: 012432
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 05/30/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2025
• Supplement Date Received by Manufacturer: 08/29/2025
• Initial Report FDA Received Date: 06/20/2025
• Supplement Report FDA Received Date: 09/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/13/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown