MAUDE Adverse Event Report: ARTHREX, INC. CAPTURED CORTICAL SCREW, Ø4.2MM X 35MM; INTRAMED FIXATN ROD AND ACCESS

Model Number	CAPTURED CORTICAL SCREW, Ø4.2MM X 35MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/11/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2023, it was reported by a sales representative via email that a 4.2 mm x 45mm distal screw and a 5.0 mm x 65 mm proximal screw fractured.When inserting the 4.2 mm screw, it completely fractured, and one-third of the screw, the threaded distal portion, needed to be removed via lateral incision and barrel reaming.The 5.0 screw was partially fractured and was pulled out completely using the hex driver and capture rod.The surgeon did not appear to be using unreasonable force and had not yet gotten the head of the reduction bolt fully threaded down.The case was completed using new cortical screws to achieve the needed compression.This was discovered during a tibial nail procedure on (b)(6) 2023.Additional information received on 9/25/2023: the part numbers involved in the procedure were an 8002-035 captured cortical screw, 4.2mm x 35mm, and an 8001-065 captured cortical screw, 5.0mm x 65mm.The case was delayed over ninety minutes, but the sales representative is unsure if additional anesthesia was administered to the patient.The case was completed using another 8002-035 captured cortical screw and an 8001-065 captured cortical screw.
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
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 error due to misaligned insertion and/or prying/leveraging the device during insertion.

• Brand Name: CAPTURED CORTICAL SCREW, Ø4.2MM X 35MM
• Common Device Name: INTRAMED FIXATN ROD AND ACCESS
• 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: emily shafer ; 8009337001
• MDR Report Key: 17919953
• Report Number: 1220246-2023-08158
• Device Sequence Number: 6804820
• Product Code: HSB
• UDI-Device Identifier: 00848665019414
• UDI-Public: 00848665019414
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K070444
• 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): 02/27/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: CAPTURED CORTICAL SCREW, Ø4.2MM X 35MM
• Device Catalogue Number: 8002-035
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2023
• Supplement Date Received by Manufacturer: 02/17/2025
• Initial Report FDA Received Date: 10/12/2023
• Supplement Report FDA Received Date: 02/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown