MAUDE Adverse Event Report: ARTHREX, INC. SUTURETAPE TIGERLOOP W/ NDL WH/BLK; POLYETHYLENE SYNTHETIC SUTURE

Model Number	SUTURETAPE TIGERLOOP W/ NDL WH/BLK
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/08/2022
Type of Reportable Event	Malfunction
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.Complaint confirmed.One unpackaged ar-7534t was received for investigation.Visual inspection identified that the nitinol loop holding the suture to the needle had split.Additionally, the distal end of the needle was noticeably bent.No damage was present to the suture loop.The observed condition is consistent with mishandling.
Event or Problem Description
On 2/9/2022 it was reported by an arthrex employee via email that an ar-7534t tigerloop suture tape loop at the end of the needle broke immediately after surgeon applied tension.Surgeon used a new product and case was completed without further issues.This was discovered during an procedure on (b)(6) 2022.Additional information received 2/10/2022: this was discovered during an acl repair procedure.The loop of the needle broke outside of the patient's body and case was completed using another ar-7534t, lot number is unknown.

• Brand Name: SUTURETAPE TIGERLOOP W/ NDL WH/BLK
• 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: 19509882
• Report Number: 1220246-2024-05543
• Device Sequence Number: 17032819
• Product Code: GAT
• UDI-Device Identifier: 00888867288867
• UDI-Public: 00888867288867
• Combination Product (Y/N): N
• PMA/510(K) Number: K171296
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/11/2024

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: 02/28/2026
• Device Model Number: SUTURETAPE TIGERLOOP W/ NDL WH/BLK
• Device Catalogue Number: AR-7534T
• Device Lot Number: 100022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2022
• Initial Report FDA Received Date: 06/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2021
• 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