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

Model Number	4-0 FIBERLOOP, 12 INCHES WITH NEEDLE
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2023
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
It was reported that, during a flexor tendon suture surgery, it was found that the needle was dull.There was no harm for patient, operator or third party reported.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.Update, khe, 18-oct-2023: the following devices were received: 1 unopened package, 1 opened package with 9 original packed needles, 2 unpacked needles.
Additional Manufacturer Narrative
Additional information: the complaint is not confirmed.One unpackaged ar-7229-12 serial/batch number 27512 was received for evaluation.It also received one sealed box that contained 12 devices and one open box with 10 sealed ar-7229-12 serial/batch number 27512.Visual evaluation of the needle under the magnifier found that the point of the needle was sharp; no issues were observed on the body of the needle.Inspection of the suture found no issues.No problem found.The most likely cause for the reported failure is a use error.

• Brand Name: 4-0 FIBERLOOP, 12 INCHES WITH NEEDLE
• 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: emily shafer ; 8009337001
• MDR Report Key: 18002192
• Report Number: 1220246-2023-08355
• Device Sequence Number: 6642802
• Product Code: GAT
• UDI-Device Identifier: 00888867041592
• UDI-Public: 00888867041592
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K122374
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2024

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 Model Number: 4-0 FIBERLOOP, 12 INCHES WITH NEEDLE
• Device Catalogue Number: AR-7229-12
• Device Lot Number: 27512
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2023
• Supplement Date Received by Manufacturer: 06/19/2024
• Initial Report FDA Received Date: 10/25/2023
• Supplement Report FDA Received Date: 11/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2022
• 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