MAUDE Adverse Event Report: ARTHREX, INC. BIOCARTILAGE KIT, SMALL JOINT; SYRINGE, PISTON

Model Number	BIOCARTILAGE KIT, SMALL JOINT
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/17/2021
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.Review of (b)(6) determined that on revision 12 of abs-1000-s the foam tip applicators were removed from the kit.Review of the dhr for abs-1000-s batch 50191838 shows that this batch was built to revision 12.As a result, the foam tip applicator should not be present.
Event or Problem Description
It was reported that the abs-1000-s delivery system did not include the foam tip applicators.Surgeon used cotton applicators that left residue in the joint and did not properly dry the surface for proper contact.The cotton applicators also broke in the joint because they were flimsy, and not what the surgeon expected to use.The procedure was completed.

• Brand Name: BIOCARTILAGE KIT, SMALL JOINT
• Common Device Name: SYRINGE, PISTON
• 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: 19195621
• Report Number: 1220246-2024-02491
• Device Sequence Number: 18218990
• Product Code: FMF
• UDI-Device Identifier: 00888867229181
• UDI-Public: 00888867229181
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K121124
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 04/26/2024

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 Model Number: BIOCARTILAGE KIT, SMALL JOINT
• Device Catalogue Number: ABS-1000-S
• Device Lot Number: 50191838
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2021
• Initial Report FDA Received Date: 04/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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