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

Model Number	DRIVER, BIOCOMPOSITE INTERFERENCE SCREW
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 28 may 2024 it was reported by a sales rep via email that an ar-1996cd driver, biocomposite interference screw broke during use.This occurred during an acl reconstruction when the screw was being inserted.The case was completed successfully.There was case involvement.
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
Additional information: d9, g3, h3, h6 the complaint allegation is not confirmed.Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to user-applied excessive force during the tightening process.

• 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: 19557799
• Report Number: 1220246-2024-05908
• Device Sequence Number: 4850540
• Product Code: LXH
• UDI-Device Identifier: 00888867025707
• UDI-Public: 00888867025707
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2025

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 Model Number: DRIVER, BIOCOMPOSITE INTERFERENCE SCREW
• Device Catalogue Number: AR-1996CD
• Device Lot Number: 47322330
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2024
• Supplement Date Received by Manufacturer: 12/31/2024
• Initial Report FDA Received Date: 06/18/2024
• Supplement Report FDA Received Date: 01/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown