MAUDE Adverse Event Report: ARTHREX, INC. LEFTY TIGHTY LAG SCREW, Ø10.5MM X 110MM; INTRAMED FIXATN ROD AND ACCESS

Model Number	LEFTY TIGHTY LAG SCREW, Ø10.5MM X 110MM
Medical Device Problem Code	Damaged Thread (4075)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 1/30/2024, it was reported by a sales representative via email that an 1192-110 telescoping lag screw left dethreaded during insertion.The case was completed using a 10.5mm x 115mm screw.This was discovered during an unspecified procedure on (b)(6) 2024, with no reported patient harm.
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.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 applying excessive mechanical forces upon insertion and/or misaligned the insertion.The complaint allegation was confirmed based on the customer's attached picture which displays the 1192-110 with the threads damaged and scratches lines on the shaft.

• Brand Name: LEFTY TIGHTY LAG SCREW, Ø10.5MM X 110MM
• 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: 18768565
• Report Number: 1220246-2024-01088
• Device Sequence Number: 15378888
• Product Code: HSB
• UDI-Device Identifier: 00848665036572
• UDI-Public: 00848665036572
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 05/29/2025

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 TIGHTY LAG SCREW, Ø10.5MM X 110MM
• Device Catalogue Number: 1192-110
• Device Lot Number: 212129
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2024
• Supplement Date Received by Manufacturer: 05/13/2025
• Initial Report FDA Received Date: 02/23/2024
• Supplement Report FDA Received Date: 05/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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