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

Model Number	JIG, PARS
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	11/13/2019
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
It was reported by the sales rep, that during an achilles rupture procedure, the surgeon placed the pars jig, ar-8860j, into the patient knowing that the pins were loose.After the pins were placed the surgeon could not pass the sutures in the order as indicated on the card.The # 1 and # 5 sutures had to be switched.The case was completed.Additional information provided 11/21/2019: the case took place on (b)(6) 2019.After removal of the jig, the sutures pulled through so the surgeon switched the black and white suture order.The case took longer than normal as the rep was troubleshooting the jig and the patient was administered additional anesthesia.Additional information 11-25-2019: per the sales rep, the surgery was extended for 45 minutes.There were no unplanned incisions.The surgeon used open krackow to complete the case.

• 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: 9443498
• Report Number: 1220246-2019-01464
• Device Sequence Number: 2208162
• Product Code: LXH
• UDI-Device Identifier: 00888867048621
• UDI-Public: 00888867048621
• 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: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/10/2019

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: 021039
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2019
• Initial Report FDA Received Date: 12/10/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other