MAUDE Adverse Event Report: ARTHREX, INC. PARS SUTURE IMPLANT KIT W/ SUTURETAPE; SUTURE, NON-ABSORBABLE, SYNTHETIC, POLYETHYLENE

Model Number	PARS SUTURE IMPLANT KIT W/ SUTURETAPE
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	11/18/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
On 11/22/2022, it was reported by a sales representative via email that a suturetape #2 and suturetape #5 from an ar-8862ds pars suturetape implant system, ruptured at the knot site while attempting to tie them by hand.In order to remove the broken sutures, surgeon opened the incision larger.This was discovered during an achilles tendon repair procedure on (b)(6) 2022.
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.

• Brand Name: PARS SUTURE IMPLANT KIT W/ SUTURETAPE
• Common Device Name: SUTURE, NON-ABSORBABLE, SYNTHETIC, POLYETHYLENE
• 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: vik bajnath ; 8009337001
• MDR Report Key: 15931052
• Report Number: 1220246-2022-05889
• Device Sequence Number: 4467998
• Product Code: GAT
• UDI-Device Identifier: M150AR8862DS1
• UDI-Public: 00888867288263
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K171296
• 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
• Report Date (Section B): 12/06/2022

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: PARS SUTURE IMPLANT KIT W/ SUTURETAPE
• Device Catalogue Number: AR-8862DS
• Device Lot Number: 14995692
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/22/2022
• Initial Report FDA Received Date: 12/07/2022
• Date Device Manufactured: 08/25/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown