MAUDE Adverse Event Report: ARTHREX, INC. BIOXPRESS GRAFT DELIVERY, 10CM BLUNT TIP; SYRINGE, PISTON

Model Number	BIOXPRESS GRAFT DELIVERY, 10CM BLUNT TIP
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/30/2021
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 sales representative via phone that an abs-10053-10 bioxpress graft delivery, black rubber tip, fell of device and into the patient.Surgeon inserted a scope and was able to locate the black tip and retrieve it.This was discovered during a subtalar fusion procedure on (b)(6) 2021.Case was completed successfully without issues.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.As per the attached vendor investigation of this adverse event, three probable root causes were considered: process issue, design issue, or user error.Based on the mitigations listed in the attached vendor investigation, and the reviews conducted, it is determined that that both process and design issues can be eliminated as the probable root cause.Vendor evaluation of the failure mode determined the failure was likely due to a user error.If the device is used as intended, the stylet stopper is unlikely to fall off into the patient due to design and process controls.The ifu (pn 21944) and tyvek lid (pn 21850) instruct the user on assembly of all the components with verbiage and pictures.This provides mitigation for the risk of the user not using all of the components during use.The ufmea for this product (91143 rev r) addresses the risk of improper component assembly.The severity of this failure is 2 or ¿minor¿.A potential user error that may lead to the stopper falling off includes the user not using all the components.If the user was to not use the cannula during device use, the stylet stopper has a higher chance of falling into the patient since the cannula would not be present to act as a barrier.The risk controls for process, design, and use failures are in place to ensure with proper use, the device is unlikely to fail.Since it cannot be determined if the device was used as intended, it is likely that user error is the probable root cause of this adverse event.

• Brand Name: BIOXPRESS GRAFT DELIVERY, 10CM BLUNT TIP
• 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: 13281885
• Report Number: 1220246-2022-04298
• Device Sequence Number: 12066089
• Product Code: FMF
• UDI-Device Identifier: 20815634020331
• UDI-Public: 20815634020331
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K151543
• 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): 05/14/2025

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: 09/30/2026
• Device Model Number: BIOXPRESS GRAFT DELIVERY, 10CM BLUNT TIP
• Device Catalogue Number: ABS-10053-10
• Device Lot Number: 322965
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/30/2021
• Supplement Date Received by Manufacturer: 05/05/2025
• Initial Report FDA Received Date: 01/18/2022
• Supplement Report FDA Received Date: 05/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/02/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown