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

Model Number BIOXPRESS GRAFT DELIVERY, 10CM BLUNT TIP

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/02/2024

Event Type  malfunction  

Event Description

On 2/2/2024, it was reported by a sales representative via (b)(4) that the black nipple from an abs-10053-10 bioxpress graft delivery, came off when injecting.The nipple could not be found, and it was left inside the patient.This was discovered during an acl procedure on (b)(6) 2024.Additional information requested.

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.

• Brand Name: BIOXPRESS GRAFT DELIVERY, 10CM BLUNT TIP
• Type of Device: 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: jared engle ; 8009337001
• MDR Report Key: 18746616
• MDR Text Key: 335817895
• Report Number: 1220246-2024-01047
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151543
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 02/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BIOXPRESS GRAFT DELIVERY, 10CM BLUNT TIP
• Device Catalogue Number: ABS-10053-10
• Device Lot Number: 255133
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/02/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/04/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1