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

Model Number	IMPLANT SYSTEM,CPR VIPER
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.Arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.The complaint device was not received for evaluation.Based off the information provided, the most likely cause for the reported failure can be attributed to user-applied excessive mechanical forces.
Event or Problem Description
On 12/03/2021, it was reported by arthrex employee via sems that a ar-8692ds implant system was unable to retrieve sutures with multiple attempts tried there was no success.This occurred during an unknown procedure, and both the representative and the surgeon attempted both during and after the operation.There was no patient effect reported.

• 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: 19201693
• Report Number: 1220246-2024-02539
• Device Sequence Number: 12767892
• Product Code: GAT
• UDI-Device Identifier: 00888867190986
• UDI-Public: 00888867190986
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/29/2024

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 Expiration Date: 08/31/2025
• Device Model Number: IMPLANT SYSTEM,CPR VIPER
• Device Catalogue Number: AR-8692DS
• Device Lot Number: 0226105740
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2021
• Initial Report FDA Received Date: 04/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown