MAUDE Adverse Event Report: ARTHREX, INC. SUTURETAPE FIBERLINK 1.3MM WH/BL; SUTURE, NON-ABSORBABLE, SYNTHETIC, POLYETHYLENE

Model Number	SUTURETAPE FIBERLINK 1.3MM WH/BL
Health Effect - Clinical Code	Pain (1994)
Date of Event	12/09/2021
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.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
On (b)(6) 2022, it was reported by a sales representative via email that an ar-2324kpslc peek knotless swivelock seems to be fraying and cutting an ar-7535 fiberlink suture tape suture when the suture comes in contact with the metal driver during tensioning.This was discovered during a revision subpec tenodesis procedure on (b)(6) 2022.This issue has caused the bicep to retract and causing patient pain.The original procedure was a biceps loop n tak.Surgeon was able to correct issue with a 2.6 knotless fibertak subpc.Onlay.

• Brand Name: SUTURETAPE FIBERLINK 1.3MM WH/BL
• 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: 13928465
• Report Number: 1220246-2022-04656
• Device Sequence Number: 19834461
• Product Code: GAT
• UDI-Device Identifier: 00888867288669
• UDI-Public: 00888867288669
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 03/28/2022

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: SUTURETAPE FIBERLINK 1.3MM WH/BL
• Device Catalogue Number: AR-7535
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2022
• Initial Report FDA Received Date: 03/28/2022
• 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