MAUDE Adverse Event Report: ARTHREX, INC. JIG, PARS; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	JIG, PARS
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
On 08/24/2021, it was reported by a sales representative via sems that an ar-8860j pars jig was not passing needles correctly.The device was hitting the inside prongs keeping the surgeon from passing suture correctly.This was discovered during use in an achilles repair on 8/24/2021. all tips and pearls were performed during the procedure the case was completed by doing an open repair.
Additional Manufacturer Narrative
The complaint is not confirmed.One ar-8860j lot 011651 was received for investigation.Visual and functional inspection revealed no issues with the device.Using a 0.063" gage it was found that the holes on the base, jig, pars (c1356-01) were within specification.

• Brand Name: JIG, PARS
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 12467496
• Report Number: 1220246-2021-03645
• Device Sequence Number: 14386615
• Product Code: LXH
• UDI-Device Identifier: 00888867048621
• UDI-Public: 00888867048621
• 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
• Report Date (Section B): 10/20/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: JIG, PARS
• Device Catalogue Number: AR-8860J
• Device Lot Number: 011651
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/24/2021
• Supplement Date Received by Manufacturer: 08/24/2021
• Initial Report FDA Received Date: 09/14/2021
• Supplement Report FDA Received Date: 10/20/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other