MAUDE Adverse Event Report: ARTHREX, INC. BIOSURGE KIT WITH 5.0CC ALLOSYNC PURE; PLATELET AND PLASMA SEPARATOR

Model Number	BIOSURGE KIT WITH 5.0CC ALLOSYNC PURE
Medical Device Problem Codes	Material Puncture/Hole (1504); No Flow (2991)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/06/2025
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
On 08/07/2025, a sales representative reported via (b)(6) that an abs-2016-02 biosurge kit with 5.0cc allosync pure, when they went to spin the bmac, it wasn¿t pulling up through the tubing, and it was making a squeaking noise.This occurred during a rotator cuff repair.They determined that there was a hole in the tubing, so they changed to a new kit, transferred the blood to the new tubing kit, and proceeded.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Complaint allegation is not confirmed.Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause of the reported failure can be attributed to the device coming into contact with another device during use and/or misuse/mishandling, due in damage to the device.

• Brand Name: BIOSURGE KIT WITH 5.0CC ALLOSYNC PURE
• Common Device Name: PLATELET AND PLASMA SEPARATOR
• 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: 22882778
• Report Number: 1220246-2025-03608
• Device Sequence Number: 15854211
• Product Code: ORG
• UDI-Device Identifier: 00888867319943
• UDI-Public: (01)00888867319943(11)250203(17)270131(10)CRT240833
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: BK180180
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2025

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: BIOSURGE KIT WITH 5.0CC ALLOSYNC PURE
• Device Catalogue Number: ABS-2016-02
• Device Lot Number: CRT240833
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2025
• Supplement Date Received by Manufacturer: 11/04/2025
• Initial Report FDA Received Date: 08/25/2025
• Supplement Report FDA Received Date: 11/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/03/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown