MAUDE Adverse Event Report: ARTHREX, INC. W/ ACD-A 13G OPEN TIP BMA ANGEL KIT; PLATELET AND PLASMA SEPARATOR FOR BONE GRAFT HANDLING

Model Number	W/ ACD-A 13G OPEN TIP BMA ANGEL KIT
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
On 12/29/2023, it was reported by a sales representative via (b)(4) that an open tip bma kit, abs-10062k-th13ota, was received with a hole in the tubing; not allowing for the blood to be drawn into the cassette.This was discovered during a brostrom procedure on (b)(6) 2023 with no patient harm.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Based on the information provided, which may include the device (if available and returned), pictures, videos, event descriptions, and any additional information from the field, arthrex concluded the cause of the reported failure.The most likely cause of the reported failure is user error.Specifically, mishandling the device.The complaint allegation was not confirmed.The device was not received for evaluation, and no evidence of the failure was provided.

• Brand Name: W/ ACD-A 13G OPEN TIP BMA ANGEL KIT
• Common Device Name: PLATELET AND PLASMA SEPARATOR FOR BONE GRAFT HANDLING
• 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: emily shafer ; 8009337001
• MDR Report Key: 18556444
• Report Number: 1220246-2024-00475
• Device Sequence Number: 6383853
• Product Code: ORG
• UDI-Device Identifier: 00888867387331
• UDI-Public: 00888867387331
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: BK190383
• 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): 03/17/2025

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: 01/01/2026
• Device Model Number: W/ ACD-A 13G OPEN TIP BMA ANGEL KIT
• Device Catalogue Number: ABS-10062K-TH13OTA
• Device Lot Number: 3241134602
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/29/2023
• Supplement Date Received by Manufacturer: 03/14/2025
• Initial Report FDA Received Date: 01/22/2024
• Supplement Report FDA Received Date: 03/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2023
• 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