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

Model Number	IMPLANT SYSTEM,CPR VIPER
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2025
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
It was reported that during a plantar plate repair surgery the leading shaft became bent.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.The complaint allegation was confirmed.One unpackaged ar-8692ds implant system, cpr¿ viper¿ with suturetape, white/blue, 1.3 mm, batch number 4113140677, was received for evaluation.Visual inspection found that the shaft of the meniscal viper and inserter were bent at the distal end close to the tip.The returned suture was found frayed.A functional test was not performed because the device was damaged.The most likely cause(s) of the reported failure are user error, misaligned insertion, or excessive forces applied by leveraging/prying the device.

• 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: 23657917
• Report Number: 1220246-2025-05219
• Device Sequence Number: 4903790
• Product Code: GAT
• UDI-Device Identifier: 00888867190986
• UDI-Public: (01)00888867190986(11)240501(17)290430(10)4113140677
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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): 03/04/2026

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
• Device Lot Number: 4113140677
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2025
• Supplement Date Received by Manufacturer: 03/03/2026
• Initial Report FDA Received Date: 11/26/2025
• Supplement Report FDA Received Date: 03/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2024
• 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