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	08/04/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
It was reported on (b)(6) 2022 by a arthrex employee via sems that an 1192-090 lag screw backed out.This was discovered during after the screw was implanted for an unspecified time, a revision surgery is planned.Revision date (b)(6) 2022.

• 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: 15250098
• Report Number: 1220246-2022-05408
• Device Sequence Number: 5808316
• 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: K120148
• 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): 08/18/2022

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 TIGHT LAG SCREW, Ø10.5MM X 90MM
• Device Catalogue Number: 1192-090
• Device Lot Number: 212113
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2022
• Initial Report FDA Received Date: 08/18/2022
• Date Device Manufactured: 10/22/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown