MAUDE Adverse Event Report: ARTHREX, INC. ANTI-ROTATION SCREW, Ø5.0MM X 90MM; INTRAMED FIXATN ROD AND ACCESS

Model Number	ANTI-ROTATION SCREW, Ø5.0MM X 90MM
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	11/25/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
It was reported that during an intertrochanteric fracture surgery the lag screw and anti-rotation screw backed out of the nail and the nail lagscrew hole looked damaged.It was further reported that the patient went in for a total hip replacement on (b)(6) 2024.
Event or Problem Description
***update 25-feb-2025.Further information was provided that the initial surgery was performed successfully.No further information was provided.
Additional Manufacturer Narrative
Complaint allegation is confirmed.-visual inspection, it was noted that the anti-rotation screw, ø5.0mm x 90mm did not have any issues/damaged, but the anti-rotation screw nail screw hole was damaged.-functional testing was performed with the nail and the device worked as required.Per surgical technique nail system: the es hole is easily targeted through the nail jig without the need for perfect circles or additional attachments or devices.Preoperative planning preoperative radiographs of the uninjured femur may be used to establish proper nail diameter, expected amount of reaming (if necessary), lag screw angle, nail length, and lag screw length.The most likely cause for the reported failure can be attributed to user error of the device due to misaligned insertion.-refer to investigation photos.-complaint allegation is confirmed.

• Brand Name: ANTI-ROTATION SCREW, Ø5.0MM X 90MM
• 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: 21392752
• Report Number: 1220246-2025-00458
• Device Sequence Number: 8471342
• Product Code: HSB
• UDI-Device Identifier: 00848665019902
• UDI-Public: 00848665019902
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/16/2025

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, Ø5.0MM X 90MM
• Device Catalogue Number: 8021-090
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2025
• Supplement Date Received by Manufacturer: Not provided; 06/24/2025
• Initial Report FDA Received Date: 02/18/2025
• Supplement Report FDA Received Date: 03/12/2025; 07/16/2025
• 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: Other
• Patient Sex: Unknown