MAUDE Adverse Event Report: ARTHREX, INC. CANNULATED HIP SCREW DRILL, Ø10.3MM; INTRAMED FIXATN ROD AND ACCESS

Model Number	CANNULATED HIP SCREW DRILL, Ø10.3MM
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 05/27/2025, a facility representative reported via (b)(4) that a 0258-000 10.3mm cannulated hip screw drill wouldn¿t fit the guidewire inside the cannulation, and it was bent.The drill could not be used at all.This occurred during a case, and no patient was affected.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.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 misaligned insertion; prying/leveraging the screw during insertion.

• Brand Name: CANNULATED HIP SCREW DRILL, Ø10.3MM
• 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: 22285003
• Report Number: 1220246-2025-02525
• Device Sequence Number: 18213319
• Product Code: LXH
• UDI-Device Identifier: 00848665014020
• UDI-Public: (01)00848665014020(11)221021(10)211874
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2025

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: CANNULATED HIP SCREW DRILL, Ø10.3MM
• Device Catalogue Number: 0258-000
• Device Lot Number: 211874
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 05/27/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2025
• Supplement Date Received by Manufacturer: 09/04/2025
• Initial Report FDA Received Date: 06/18/2025
• Supplement Report FDA Received Date: 09/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/21/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown