MAUDE Adverse Event Report: ARTHREX, INC. LEFTY TIGHTY LAG SCREW, Ø10.5MMX100MM; INTRAMED FIXATN ROD AND ACCESS

Model Number	LEFTY TIGHTY LAG SCREW, Ø10.5MMX100MM
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/27/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
On 9/10/2024, it was reported by a sales representative via phone that a 0857-100 capturing rod and 1192-100 lefty tighty lag screw got stuck together and could not be taken apart.This was discovered during a troch nail procedure on (b)(6) 2024.The case was completed using a new 0857-100 capturing rod and 1192-100 lefty tightly lag screw.Additional information received on 9/27/2024: it was noticed after the surgery that the 0857-100 capturing rod and 1192-100 lefty tighty lag screw got stuck together.Additional information received on 10/4/2024: this occurred during a revision surgery.The screw had collapsed all the way and ended up cutting through the head.All products were removed, and the case was completed as a total hip procedure.The original surgery was performed on (b)(6) 2024.Both surgeries were performed at the same facility and by the same surgeon.
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 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 of the device due to misaligned insertion.

• Brand Name: LEFTY TIGHTY LAG SCREW, Ø10.5MMX100MM
• 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: 20463005
• Report Number: 1220246-2024-08166
• Device Sequence Number: 8767903
• Product Code: HSB
• UDI-Device Identifier: 00848665036558
• UDI-Public: 00848665036558
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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): 06/10/2025

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: LEFTY TIGHTY LAG SCREW, Ø10.5MMX100MM
• Device Catalogue Number: 1192-100
• Device Lot Number: 230094
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2024
• Supplement Date Received by Manufacturer: 06/01/2025
• Initial Report FDA Received Date: 10/16/2024
• Supplement Report FDA Received Date: 06/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2023
• 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