MAUDE Adverse Event Report: ARTHREX, INC. IMPLANT SYSTEM,CPR VIPER; POLYETHYLENE SYNTHETIC SUTURE

Model Number	IMPLANT SYSTEM,CPR VIPER
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 18 april 2024, it was reported by field staff via email that there had been an incident with an ar-8692ds 4 implant system, cpr viper.On (b)(6) 2024 in southern cross christchurch hospital, the surgeon used the cpr viper for a first pass of suture in a 2nd ray plantar plate repair.When the needle had passed through the end of the cpr viper it got caught and would not retract.The case was completed successfully through the use of another cpr viper.There was case/patient involvement.
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.Based on the images provided from the field, arthrex concluded a most likely cause.The reported failure can be attributed to user-applied excessive force during the tightening process.

• Brand Name: IMPLANT SYSTEM,CPR VIPER
• 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: 19311942
• Report Number: 1220246-2024-03248
• Device Sequence Number: 16919721
• Product Code: GAT
• UDI-Device Identifier: 00888867190986
• UDI-Public: 00888867190986
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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): 06/12/2025

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: IMPLANT SYSTEM,CPR VIPER
• Device Catalogue Number: AR-8692DS
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2024
• Supplement Date Received by Manufacturer: 05/18/2025
• Initial Report FDA Received Date: 05/14/2024
• Supplement Report FDA Received Date: 06/12/2025
• 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