MAUDE Adverse Event Report: ARTHREX, INC. SUTURETAPE 1.3 BLK/WH W/TPR NDL 36.6MM; POLYETHYLENE SYNTHETIC SUTURE

Model Number	SUTURETAPE 1.3 BLK/WH W/TPR NDL 36.6MM
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 01/09/2024, it was reported by a sales representative via e-mail that an ar-7506t suturetape was defective.This occurred during a case upon being opened.The case was completed with no harm to the patient.
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.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Evaluation of the customer's photograph of an alleged ar-7506t batch 15019722, suturetape, 1.3 mm suture, black/white with ½ circle needle, 36.6 mm, ve12.It was noted that the suture tape was frayed and had filaments out of the construction along the tape, most likely as a result of the device being tensioned against a hard bone or an instrument during use.Based on the information provided, which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely reason for the reported failure is user error.Direction for use.Dfu-0222-eor2_fmt_en g.Precautions 2.In handling this or any other suture material, care should be taken to avoid damage from handling.Avoid crushing or crimping damage due to application of surgical instruments such as forceps or needle holders.The complaint allegation of the device being defective was confirmed.The allegation upon opening cannot be confirmed as the photograph (b)(4) customer photo.Jpeg and (b)(4) customer photo 2.Jpeg shows the device being used.

• Brand Name: SUTURETAPE 1.3 BLK/WH W/TPR NDL 36.6MM
• 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: 18608657
• Report Number: 1220246-2024-00613
• Device Sequence Number: 9033960
• Product Code: GAT
• UDI-Device Identifier: 00888867341593
• UDI-Public: 00888867341593
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K193575
• 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,Followup
• Report Date (Section B): 01/30/2025

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: SUTURETAPE 1.3 BLK/WH W/TPR NDL 36.6MM
• Device Catalogue Number: AR-7506T
• Device Lot Number: 15019722
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2024
• Supplement Date Received by Manufacturer: 01/06/2025
• Initial Report FDA Received Date: 01/30/2024
• Supplement Report FDA Received Date: 01/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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