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
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/22/2021
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2021, it was reported by a sales representative via email that an 1192-090 lefty tight lag screw broke.This was discovered during a procedure on (b)(6) 2021.When the surgeon attempted to advance the screw, it broke inside the patient.The screw was retrieved and was replaced with an 1099-090 galileo lag screw.
Additional Manufacturer Narrative
Complaint confirmed.Upon visual inspection, it was noted that the second thread was broken off.The broken piece was not returned for evaluation.The cause of this remains undetermined.

• 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: vik bajnath ; 8009337001
• MDR Report Key: 15200736
• Report Number: 1220246-2022-05354
• Device Sequence Number: 4582012
• Product Code: HSB
• UDI-Device Identifier: 00848665036534
• UDI-Public: 00848665036534
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Report Date (Section B): 08/10/2022

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
• Device Model Number: LEFTY TIGHT LAG SCREW, Ø10.5MM X 90MM
• Device Catalogue Number: 1192-090
• Device Lot Number: 202340
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/23/2021
• Initial Report FDA Received Date: 08/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown