MAUDE Adverse Event Report: ARTHREX, INC. MENISCL VIPER REPR KIT,DISP,MED; POLYETHYLENE SYNTHETIC SUTURE

Model Number	MENISCL VIPER REPR KIT,DISP,MED
Medical Device Problem Codes	Break (1069); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 04/24/2025, an arthrex subsidiary employee reported via email that an ar-13930ds meniscal viper repair disposable kit had resistance when pushing the needle out, and it did not catch the thread well.The thread broke three times when trying to forcefully pull it out.The case was completed with another ar-13930ds meniscal viper repair disposable kit.This was discovered during a procedure on (b)(6) 2025, with no reported patient harm.Additional information received on 5/19/2025: this issue occurred in the patient during a meniscus repair procedure, and all the broken fragments were removed.The case was not delayed, and additional anesthesia was not needed.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint device was not received for evaluation.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 the most likely cause.The most likely cause of the reported failure is user error, including improper device surgical technique.The complaint allegation could not be confirmed, as the device was not received for evaluation, and no evidence of the reported failure was provided.

• Brand Name: MENISCL VIPER REPR KIT,DISP,MED
• 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: 22176621
• Report Number: 1220246-2025-02423
• Device Sequence Number: 7957743
• Product Code: GAT
• UDI-Device Identifier: 00888867015715
• UDI-Public: (01)00888867015715(11)250101(17)291231(10)5013155949
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K021434
• 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): 10/13/2025

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: MENISCL VIPER REPR KIT,DISP,MED
• Device Catalogue Number: AR-13930DS
• Device Lot Number: 5013155949
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2025
• Supplement Date Received by Manufacturer: 10/07/2025
• Initial Report FDA Received Date: 06/10/2025
• Supplement Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/01/2025
• 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