MAUDE Adverse Event Report: ARTHREX, INC. ANTI-ROTATION SCREW, 5.0 MM X 80 MM; INTRAMED FIXATN ROD AND ACCESS

Model Number	ANTI-ROTATION SCREW, 5.0 MM X 80 MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/23/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On 04/24/2025, a sales representative reported via email that an ar-9094-09l telescoping lag screw was inserted for a left hip during a intertrochanteric hip fracture on (b)(6) 2025.During the insertion, the surgeon turned the screw, causing its threads to shear off.As a result, adjustments had to be made to the ar-9094ar-080 anti-rotation screw, and the procedure required transitioning to a regular lag screw.This issue extended the operation by approximately one hour.The surgeon made efforts to retrieve as many of the broken metal threads as possible; however, some remained visible on the postoperative x-ray.Additionally, the anti-rotation screw required further adjustment and downsizing due to the issue.Despite the surgeon's attempts to remove the remaining fragments before closure, not all could be retrieved.This was discovered during use.Additional information has been requested.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint allegation is confirmed based on the photo provided by the customer.Arthrex was able to conclude a most likely cause.The most likely cause of the reported failure is user error in using the device, which resulted in the user applying excessive mechanical forces upon insertion and not following the surgical technique.Trochanteric nail implant system 6.Pre-operative and operating procedures, including knowledge of surgical techniques and proper selection and placement of the device, are important considerations in the successful utilization of this device.The appropriate arthrex delivery system is required for the proper implantation of the device.

• Brand Name: ANTI-ROTATION SCREW, 5.0 MM X 80 MM
• 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: jared engle ; 8009337001
• MDR Report Key: 22047652
• Report Number: 1220246-2025-02109
• Device Sequence Number: 21097655
• Product Code: HSB
• UDI-Device Identifier: 00888867410732
• UDI-Public: 00888867410732
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K230257
• 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): 10/08/2025

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: ANTI-ROTATION SCREW, 5.0 MM X 80 MM
• Device Catalogue Number: AR-9094AR-080
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 04/24/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2025
• Supplement Date Received by Manufacturer: 10/02/2025
• Initial Report FDA Received Date: 05/19/2025
• Supplement Report FDA Received Date: 10/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown