MAUDE Adverse Event Report: ARTHREX, INC. ARTHREX ANGEL PRP KIT; PLATELET AND PLASMA SEPARATOR FOR BONE GRAFT HANDLING

Lot Number	4256152686
Health Effect - Clinical Code	Rupture (2208)
Date of Event	12/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
During an ortho appointment, patient was to receive prp injection to left knee.Arthrex angel prp kit was utilized.Arthrex angel prp kit; unit #: (b)(4) abs-10061t, lot: 4256152686, exp: 2026-08-31.This kit did not perform as expected in the centrifuge table.The centrifuge is used to separate blood components and the plasma is funneled into a syringe yielding 5cc of plasma.This time the components were not separated appropriately yielding approximated 9cc of partially separated fluids.Thus, another blood specimen was needed from patient.During the patient's appointment 120 ml of blood is drawn to be used in the centrifuge.Using the kits, the specimen is then separated into its components, allowing the prp to be performed.Because the separation did not occur, the blood draw had to be repeated and the specimen placed in the centrifuge, utilizing a fresh kit.Arthrex angel prp kit; unit #: (b)(4), ref: abs- 10061t, lot: 4256152686, exp: 2026-08-31.Smaller veins had to accessed, several collapse or vein to rupture.

• Brand Name: ARTHREX ANGEL PRP KIT
• Common Device Name: PLATELET AND PLASMA SEPARATOR FOR BONE GRAFT HANDLING
• Manufacturer (Section D): ARTHREX, INC.
• MDR Report Key: 21085688
• Report Number: MW5164349
• Device Sequence Number: 17834137
• Product Code: ORG
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Voluntary
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/02/2025

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 Expiration Date: 08/31/2026
• Device Lot Number: 4256152686
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/06/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 33 YR
• Patient Sex: Male
• Patient Race: White