MAUDE Adverse Event Report: ARTHREX, INC. BIOSURGE KIT WITH 5.0CC ALLOSYNC PURE; PLATELET AND PLASMA SEPARATOR FOR BONE GRAFT HANDLING

Model Number	BIOSURGE KIT WITH 5.0CC ALLOSYNC PURE
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported on 12/28/2022 by a sales representative via email that an abs-2016-02 biosurge kit leaks.Case involvement, no patient effect.Per facility: "completing a facl and when mixing the allosync pure, autologous bone from the graftnet and prp in a ratio of 5:3-5:1, all of the liquid prp came squeezing out, essentially drying up the bone graft material and making for difficulty implanting." confirmed via email on 1/23/2023 that blood did leak from the syringe into the sterile field.
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.
Additional Manufacturer Narrative
Since the complaint device was not returned, a physical evaluation of the device was not performed.However, the reported event is not confirmed without the device being returned or any photos provided.The most likely cause for the reported failure can be attributed to user error of the device due to misaligned insertion.

• Brand Name: BIOSURGE KIT WITH 5.0CC ALLOSYNC PURE
• 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: vik bajnath ; 8009337001
• MDR Report Key: 16327783
• Report Number: 1220246-2023-06240
• Device Sequence Number: 6419955
• Product Code: ORG
• UDI-Device Identifier: 00888867319943
• UDI-Public: 00888867319943
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 09/30/2024

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: 07/31/2024
• Device Model Number: BIOSURGE KIT WITH 5.0CC ALLOSYNC PURE
• Device Catalogue Number: ABS-2016-02
• Device Lot Number: 210591840
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/28/2022
• Supplement Date Received by Manufacturer: 06/07/2024
• Initial Report FDA Received Date: 02/08/2023
• Supplement Report FDA Received Date: 09/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/14/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown