MAUDE Adverse Event Report: ARTHREX, INC. 4-0 FIBERLOOP, 12 INCHES WITH NEEDLE; SUTURE, NON-ABSORBABLE, SYNTHETIC, POLYETHYLENE

Model Number	4-0 FIBERLOOP, 12 INCHES WITH NEEDLE
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/24/2021
Type of Reportable Event	Malfunction
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) 2021, it was reported by a sales representative via sems that an ar-7229-12 fiberloop had the needle separate from the fiberwire after passing through the tissue.This was discovered during use in a ucl internal brace procedure performed on (b)(6) 2021.The broken piece of needle was successfully retrieved from the patient and the procedure was completed.The representative claimed that this issue has happened multiple times in unspecified procedures with the fiberloops in the batch they have.

• Brand Name: 4-0 FIBERLOOP, 12 INCHES WITH NEEDLE
• Common Device Name: SUTURE, NON-ABSORBABLE, SYNTHETIC, POLYETHYLENE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 12467630
• Report Number: 1220246-2021-03648
• Device Sequence Number: 11739303
• Product Code: GAT
• UDI-Device Identifier: 00888867041592
• UDI-Public: 00888867041592
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K122374
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 09/14/2021

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: 11/30/2022
• Device Model Number: 4-0 FIBERLOOP, 12 INCHES WITH NEEDLE
• Device Catalogue Number: AR-7229-12
• Device Lot Number: 18684
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2021
• Initial Report FDA Received Date: 09/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1