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

Model Number JIG, PARS

Device Problems Mechanical Problem (1384); Difficult to Advance (2920)

Patient Problem Insufficient Information (4580)

Event Date 08/24/2021

Event Type  malfunction  

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 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.

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
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 12467496
• MDR Text Key: 271290742
• Report Number: 1220246-2021-03645
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 00888867048621
• UDI-Public: 00888867048621
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: JIG, PARS
• Device Catalogue Number: AR-8860J
• Device Lot Number: 011651
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/24/2021
• Initial Date FDA Received: 09/14/2021
• Supplement Dates Manufacturer Received: 08/24/2021
• Supplement Dates FDA Received: 10/20/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other