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

Model Number	BIOCARTILAGE KIT, LARGE JOINT
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/16/2026
Type of Reportable Event	Serious Injury
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 the patellofemoral autocart procedure, the tip of the swab had become detached in the patient´s knee.Since the detached piece could not be retrieved using minimally invasive techniques, it was necessary to switch from an arthroscopic surgical technique to an open surgical technique.However, the tip of the swab could not be removed.The surgery was finished successfully.It was not reported that the patient is experiencing discomfort due to the incident.It was not necessary to do a second surgery.

• Brand Name: BIOCARTILAGE KIT, LARGE 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: 24828332
• Report Number: 1220246-2026-02087
• Device Sequence Number: 10430327
• Product Code: FMF
• UDI-Device Identifier: 00888867229198
• UDI-Public: (01)00888867229198(11)241114(17)290331(10)79064324
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 04/09/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: BIOCARTILAGE KIT, LARGE JOINT
• Device Catalogue Number: ABS-1000-L
• Device Lot Number: 79064324
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2026
• Initial Report FDA Received Date: 04/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/14/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown