MAUDE Adverse Event Report: ARTHREX, INC. DRIVER, BIOCOMPOSITE INTERFERENCE SCREW; ORTHOPEDIC MANUAL SURG INSTR

Model Number	DRIVER, BIOCOMPOSITE INTERFERENCE SCREW
Medical Device Problem Code	Material Erosion (1214)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.Arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.Complaint confirmed.One unpackaged ar-1996cd, batch 47321744 driver was received for investigation.Visual inspection identified that the silicone coating across the handle was chipping at the distal end of the device.The observed condition of the device is consistent with wear and tear damage accumulated over repeated usage.
Event or Problem Description
It was reported that the coating is coming off the device.

• Brand Name: DRIVER, BIOCOMPOSITE INTERFERENCE SCREW
• Common Device Name: ORTHOPEDIC MANUAL SURG INSTR
• 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: 19081318
• Report Number: 1220246-2024-01949
• Device Sequence Number: 12823988
• Product Code: LXH
• UDI-Device Identifier: 00888867025707
• UDI-Public: 00888867025707
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 04/10/2024

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 Model Number: DRIVER, BIOCOMPOSITE INTERFERENCE SCREW
• Device Catalogue Number: AR-1996CD
• Device Lot Number: 47321744
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2021
• Initial Report FDA Received Date: 04/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/22/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown