MAUDE Adverse Event Report: ARTHREX, INC. BIOSURGE KIT WITH 2.5CC ALLOSYNC PURE; PLATELET AND PLASMA SEPARATOR

Model Number	BIOSURGE KIT WITH 2.5CC ALLOSYNC PURE
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2025
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 11/07/2025, it was reported by a sales representative via (b)(4) that an abs-10060r angel centrifuge was giving an error message stating that the lid is not closed.The magnet responsible for holding the lid closed was detached and later reattached, but the error continued to be given and the centrifuge could not be used.This was discovered during a procedure with no patient harm.
Additional Manufacturer Narrative
Based on the information provided ¿ which may include the returned device (if available), photographs, videos, event description, and any additional field input ¿ arthrex has determined the most likely cause.The most likely cause is attributed to user-related factors such as accidental impact, magnet misalignment, or incorrect reattachment position.

• Brand Name: BIOSURGE KIT WITH 2.5CC 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: 23680549
• Report Number: 1220246-2025-05259
• Device Sequence Number: 13213450
• Product Code: ORG
• UDI-Device Identifier: 00888867319936
• UDI-Public: 00888867319936
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: BK180180
• 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
• Report Date (Section B): 03/23/2026

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 2.5CC ALLOSYNC PURE
• Device Catalogue Number: ABS-2016-01
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2025
• Supplement Date Received by Manufacturer: 03/20/2026
• Initial Report FDA Received Date: 12/01/2025
• Supplement Report FDA Received Date: 03/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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