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	10/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 10/09/2024, it was reported by a sales representative via (b)(4) that an ar-8860j jig, pars was not operating correctly; the needles could barely fit through the holes (see video attachment).The surgeon had to mallet the needles to be able to get them to pass through the jig.This was discovered during a procedure, with no reported patient harm.Additional information has been requested.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
Additional information was received on 10/15/2024: this was discovered during a procedure on (b)(6) 2024.The case was completed using the standard prone according to the technique and they malleted the wires through the pars jig.The case was delayed roughly 30 minutes.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.The complaint allegation is confirmed.One unpackaged ar-8860j jig, pars batch 011923 was received for evaluation.Visual inspection revealed signs of wear as the laser marks were faded.Multiples scratched and bent were noted on the right and left arms and jig base.Functional testing was not performed as the device was damaged.The most likely cause of the reported failure is wear and tear over repetitive use and processing.

• 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: 20525964
• Report Number: 1220246-2024-08256
• Device Sequence Number: 7983632
• Product Code: LXH
• UDI-Device Identifier: 00888867048621
• UDI-Public: (01)00888867048621(11)190607(10)011923
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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,Followup
• Report Date (Section B): 02/04/2025

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: 011923
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2024
• Supplement Date Received by Manufacturer: Not provided; 01/07/2025
• Initial Report FDA Received Date: 10/24/2024
• Supplement Report FDA Received Date: 11/07/2024; 02/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/07/2019
• 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