MAUDE Adverse Event Report: ARTHREX, INC. LOCKING TOOL, GALILEO® LAG SCREW; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	LOCKING TOOL, GALILEO® LAG SCREW
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2022
Type of Reportable Event	Malfunction
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
On 9/6/2022, it was reported by a sales representative via sems that an 0456-100 locking tool, galileo® lag screw had an issue.During a trocherantic femur/troch nail procedure on (b)(6) 2022, the galileo lag screw inserter broke while inserting a lag screw on a trochanteric femur fracture.The inserter broke where the lag screw attached to the black handle.A piece broke off inside the patient, the broken piece was retrieved from the patient and the case was completed successfully.This was discovered during use with no impact to the patient.
Additional Manufacturer Narrative
The complaint is confirmed.(1) unpackaged 0456-100 was received for evaluation.Visual inspection noted the distal tip geometry used for locking had broken.The pattern of the fracture indicates stress caused by excessive torque.Without additional information, the root cause remains undetermined.A probable cause could be attributed to excessive application of mechanical forces via over-torquing the device when attempting to lock it.

• Brand Name: LOCKING TOOL, GALILEO® LAG SCREW
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: 15484297
• Report Number: 1220246-2022-05544
• Device Sequence Number: 17446298
• Product Code: LXH
• UDI-Device Identifier: 00848665021448
• UDI-Public: 00848665021448
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 11/30/2022

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
• Operator of Device: Health Professional
• Device Model Number: LOCKING TOOL, GALILEO® LAG SCREW
• Device Catalogue Number: 0456-100
• Device Lot Number: 14129
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2022
• Supplement Date Received by Manufacturer: 09/06/2022
• Initial Report FDA Received Date: 09/26/2022
• Supplement Report FDA Received Date: 11/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown