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

Model Number	PARS SUTURE IMPLANT KIT W/ SUTURETAPE
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/17/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On 03/18/2022, it was reported by a sales representative via email that an ar-8862ds pars suturetape implant system, two suturetapes broke.After tying each set of sutures, surgeon dorsiflexed the foot to test the integrity of the repair when a "pop" sound was heard.Initially it thought the suture knots came undone, but after further inspection, it was realized that two of the suturetapes snapped about 10mm above where the knots were tied.There was no fraying of the suturetape.This was discovered during an end to end pars procedure on (b)(6) 2022.Additional information received 3/21/2021: all the broken sutures were removed from inside the patient and case was completed with a new pars suturetape kit from the same lot number.
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.  arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The most likely cause for the reported failure can be attributed to user error of the device due to excessive force used during suture passing/tightening /tensioning.As no further investigation was able to be performed no change in harm was identified.This complaint will be included in trending per (b)(4).

• Brand Name: PARS SUTURE IMPLANT KIT W/ SUTURETAPE
• Common Device Name: POLYETHYLENE SYNTHETIC SUTURE
• 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: 19384984
• Report Number: 1220246-2024-03764
• Device Sequence Number: 7025345
• Product Code: GAT
• UDI-Device Identifier: 00888867288263
• UDI-Public: 00888867288263
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/23/2024

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 Expiration Date: 06/30/2026
• Device Model Number: PARS SUTURE IMPLANT KIT W/ SUTURETAPE
• Device Catalogue Number: AR-8862DS
• Device Lot Number: 13674133
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2022
• Initial Report FDA Received Date: 05/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/07/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown