MAUDE Adverse Event Report: ARTHREX, INC. ACP + ACD-A KIT; PLATELET AND PLASMA SEPARATOR FOR BONE GRAFT HANDLING

Model Number	ACP + ACD-A KIT
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2021
Type of Reportable Event	Serious Injury
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
It was reported that the seal on the abs-10011t double syringe was compromised.Prp was to be injected at the end of the operative foot procedure, but the doctor was not interested in waiting for a new blood draw and spin.The rep reported there was blood on the outer tip of the syringe.The rep stated it is hard to tell if the fluid leaked out of the tip, or leaked out of a compromised part of the syringe.

• Brand Name: ACP + ACD-A KIT
• Common Device Name: PLATELET AND PLASMA SEPARATOR FOR BONE GRAFT HANDLING
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11841503
• Report Number: 1220246-2021-03092
• Device Sequence Number: 3747713
• Product Code: ORG
• UDI-Device Identifier: 00888867316539
• UDI-Public: 00888867316539
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: BK190406
• 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
• Report Date (Section B): 05/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: ACP + ACD-A KIT
• Device Catalogue Number: ABS-10011T
• Device Lot Number: 0044101283
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2021
• Initial Report FDA Received Date: 05/18/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other