MAUDE Adverse Event Report: ARTHREX, INC. BIOCOMPOSITE, MENISCAL ROOT REPAIR KIT; BIO SOFT TISSUE FIXATN FASTNR

Model Number	BIOCOMPOSITE, MENISCAL ROOT REPAIR KIT
Medical Device Problem Codes	Break (1069); Failure to Capture (1081)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/07/2024
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 06/07/2024, it was reported by a sales representative via (b)(4) that an ar-4550bc implant system malfunctioned when passing the suture with knee scorpion through the meniscus the suture would not capture on the trap door.This occurred during a meniscal repair where they tried to fire the scorpion outside of the patient and the needle tip broke off.
Additional Manufacturer Narrative
Complaint allegation is confirmed.One (1) unpackaged, unk (part of implant system, ar-4550bc, batch 15106331), scorpion needle, batch unk, was received for evaluation.Visual inspection noted the needle was broken at the distal end.Functional testing was not performed due to the damage of the device.The most likely cause for the reported failure can be attributed to user error of the device due to excessive force being used during firing of the needle and/or unsecure grasp of tissue.Dfu-0392-sub-eo warns against the usages listed to help avoid needle breakage and potential patient injury.
Additional Manufacturer Narrative
Additional information: b5, h3, h6.
Event or Problem Description
Additional information was provided on 06/11/2024 where the sales representative stated that the device broke outside the patient.The last piece was lost in the draping.The case continued using a fiberstich.

• Brand Name: BIOCOMPOSITE, MENISCAL ROOT REPAIR KIT
• Common Device Name: BIO SOFT TISSUE FIXATN FASTNR
• 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: 19674181
• Report Number: 1220246-2024-06585
• Device Sequence Number: 6624692
• Product Code: MAI
• UDI-Device Identifier: 00888867307551
• UDI-Public: 00888867307551
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K192441
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/16/2024

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: 05/31/2025
• Device Model Number: BIOCOMPOSITE, MENISCAL ROOT REPAIR KIT
• Device Catalogue Number: AR-4550BC
• Device Lot Number: 15106331
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2024
• Supplement Date Received by Manufacturer: 09/17/2024; Not provided
• Initial Report FDA Received Date: 07/04/2024
• Supplement Report FDA Received Date: 09/25/2024; 12/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/20/2023
• 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