MAUDE Adverse Event Report: ARTHREX, INC. LEFTY TIGHTY LAG SCREW, Ø10.5MM X 105MM; INTRAMED FIXATN ROD AND ACCESS

Model Number	LEFTY TIGHTY LAG SCREW, Ø10.5MM X 105MM
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint allegation is confirmed.One unpackaged 1192-105 serial/batch number (b)(6) was received for investigation.Functional tests don't apply to this device.Visual inspection observed damage on the threaded shaft.Part of the threaded cutting flutes were peeled off.The method of bone preparation employed during the procedure, as well as the bone quality encountered, was not provided.The most likely cause(s) for the reported failure can be a user error due to improper bone preparation, misaligned insertion, and/or prying/levering the device during insertion.
Event or Problem Description
On 03/07/2024, it was reported by a sales representative via e-mail that (2) 1192-105 telescoping lag screws would not advance into the femoral head.This occurred during an im nail left hip case on (b)(6) 2024 upon x-ray review, it was noticed that the threads on the lag screw were stripped off of the screws.No additional information was provided, and additional information has been asked.Additional information received on 3/1/2024: not all the debris was removed from inside the patient.The case was com[leted using regular threaded lag screw.

• Brand Name: LEFTY TIGHTY LAG SCREW, Ø10.5MM X 105MM
• 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: 19724863
• Report Number: 1220246-2024-06712
• Device Sequence Number: 20914982
• Product Code: HSB
• UDI-Device Identifier: 00848665036565
• UDI-Public: 00848665036565
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• 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
• Report Date (Section B): 07/11/2024

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: LEFTY TIGHTY LAG SCREW, Ø10.5MM X 105MM
• Device Catalogue Number: 1192-105
• Device Lot Number: 212126
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2024
• Initial Report FDA Received Date: 07/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/06/2021
• 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
• Patient Sex: Unknown