MAUDE Adverse Event Report: ARTHREX, INC. LEFTY TIGHT LAG SCREW, Ø10.5MM X 90MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	LEFTY TIGHT LAG SCREW, Ø10.5MM X 90MM
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 01/07/2025, it was reported by a sales representative via email that an 1192-090 left lag screw would not advance through the nail and was spinning instead.The surgeon tried multiple times to redrill and reinsert the screw without success and deemed it not functional.No pieces broke off inside the patient.The surgeon proceeded to implant a standard right-threaded lag screw which was implanted successfully.This was discovered during a hip fracture procedure on (b)(6) 2025, with no reported patient harm.Additional information has been requested.Additional information received on 1/20/2025: the case was completed using a 1099-090 telescoping lag screw.The case was not delayed, and additional anesthesia was not needed.The patient was not harmed.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.The complaint allegation is confirmed.One unpackaged 1192-090 serial/batch number (b)(6), was received for investigation.Visual inspection noted signs of damage along the device's threads.Additionally, the compression sleeve was returned intact.Functional testing was not performed due to the nicks noticed along the returned device.The most likely cause of the reported failure is user error due to misaligned insertion and/or improper bone preparation.

• Brand Name: LEFTY TIGHT LAG SCREW, Ø10.5MM X 90MM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• 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: 21293645
• Report Number: 1220246-2025-00135
• Device Sequence Number: 7585949
• Product Code: HSB
• UDI-Device Identifier: 00848665036534
• UDI-Public: (01)00848665036534(11)211022(10)212113
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K202099
• 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): 04/09/2025

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: LEFTY TIGHT LAG SCREW, Ø10.5MM X 90MM
• Device Catalogue Number: 1192-090
• Device Lot Number: 212113
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2025
• Supplement Date Received by Manufacturer: 03/27/2025
• Initial Report FDA Received Date: 02/03/2025
• Supplement Report FDA Received Date: 04/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/22/2021
• 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