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 Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2023
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
On (b)(6) 2023, it was reported by an arthrex employee via email that an ar-13930ds meniscal viper tip broke off during insertion.The broken fragments were retrieved, and the case was completed using a new ar-13930ds meniscal viper.This was discovered during a procedure on (b)(6) 2023.Additional information received (b)(6) 2023: this was discovered during a meniscus repair procedure.
Additional Manufacturer Narrative
Complaint is confirmed.One unpackaged ar-13930ds was received for investigation.Visual evaluation noted that the tip of the meniscal cinch was broken off.The tip was not returned for evaluation.Functional testing was not performed due to the damage to the tip of the meniscal cinch.The most likely reason for the reported failure is the excessive force used to pry and/or leverage the device.

• 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: vik bajnath ; 8009337001
• MDR Report Key: 16869421
• Report Number: 1220246-2023-06668
• Device Sequence Number: 5478152
• 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): 10/09/2023

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: 2292126230
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2023
• Supplement Date Received by Manufacturer: 04/10/2023
• Initial Report FDA Received Date: 05/04/2023
• Supplement Report FDA Received Date: 10/09/2023
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown