MAUDE Adverse Event Report: ARTHREX, INC. ARTHREX ACP DOUBLE SYRINGE SYSTEM; SYRINGE, PISTON

Model Number	ARTHREX ACP DOUBLE SYRINGE SYSTEM
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2021
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 (b)(6) 2021 it was reported by a distributor via sems that an abs-10010s double syringe leaked prp from plunger during injection.This was discovered during a prp therapy procedure, surgeon used a new double syringe to complete case.No patient affected.
Additional Manufacturer Narrative
The complaint is not confirmed.One unpackaged abs-10010s was received for investigation.Visual and functional evaluation did not reveal any abnormality with the device.The device functioned as intended without disassembling and did not leak when tested with water.

• Brand Name: ARTHREX ACP DOUBLE SYRINGE SYSTEM
• 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: vik bajnath ; 8009337001
• MDR Report Key: 12576862
• Report Number: 1220246-2021-03749
• Device Sequence Number: 19963991
• Product Code: FMF
• UDI-Device Identifier: 00888867083790
• UDI-Public: 00888867083790
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: BK070069
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2021

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: 04/30/2024
• Device Model Number: ARTHREX ACP DOUBLE SYRINGE SYSTEM
• Device Catalogue Number: ABS-10010S
• Device Lot Number: 0122103458
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2021
• Supplement Date Received by Manufacturer: 09/16/2021
• Initial Report FDA Received Date: 10/05/2021
• Supplement Report FDA Received Date: 12/10/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown