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 Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 6/11/2024, an arthrex subsidiary employee reported via sems-(b)(4) that an ar-13930ds meniscal viper repair disposable kit had a significantly different resistance than usual, which was noticed by feel.They tried to use the device, but the suture broke.The case was completed by using a non-arthrex product.This was discovered upon opening the package during a procedure on (b)(6) 2024, with no reported patient harm.Additional information received on 6/20/2024: the broken suture was removed from the patient.This was discovered during a meniscal repair on (b)(6) 2024.No case delay reported.
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
The complaint allegation was confirmed.One unpackaged ar-13930ds batch number 3222134125 was received for investigation.Visual inspection revealed that the shaft of the knot pusher was bent at the distal end at the tip.Regular signs of wear were observed on the meniscal viper and a slightly bent of the tip.The device history records indicate that four aql samples underwent force testing and passed.Each of the aql samples exceeded 12 lbs.Certificated of conformance certified the device is in compliance with drawings specifications.Functional testing was not performed as both devices were received bent.The most probably cause of reported failure is an excessive force during use.

• 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: 19689093
• Report Number: 1220246-2024-06614
• Device Sequence Number: 17931187
• Product Code: GAT
• UDI-Device Identifier: 00888867015715
• UDI-Public: 00888867015715
• 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): 09/25/2024

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: MENISCL VIPER REPR KIT,DISP,MED
• Device Catalogue Number: AR-13930DS
• Device Lot Number: 3222134125
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2024
• Supplement Date Received by Manufacturer: 09/17/2024
• Initial Report FDA Received Date: 07/08/2024
• Supplement Report FDA Received Date: 09/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2023
• 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