MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. SI-LOK; SURGICAL SCREWDRIVER, REUSABLE

Model Number	639.650
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No part was received, so no physical evaluation could be conducted.No adverse effects to the patient were noted based on the event evaluation form.It was confirmed that there were no adverse effects to the patient.It was claimed that appropriate technique was used and that a 7.5mm drill was used for a 10mm diameter screw.This complaint will be reopened for further investigation if more information is received.No determinations can be made for the cause of the reported issue at the moment, but as the hazard/failure category most closely aligned with the available information is "tip deformation or breakage".The overall risk level would equate to low.This evaluation determined that this failure was within the expected risk profile; therefore, no further actions will be taken at this time.
Event or Problem Description
It was reported that the tip of driver broke off in surgery.The surgeon was on the last screw and felt it snap, didn't inspect it and didn't notice anything in the patient when taking final xrays.At post op visit and xrays weeks later, noticed the tip had dislodged from the screw head and was visible on xray.It is causing no issues and dr doesn't plan on doing any removal at this time.

• Brand Name: SI-LOK
• Common Device Name: SURGICAL SCREWDRIVER, REUSABLE
• Manufacturer (Section D): GLOBUS MEDICAL, INC.; 2560 general armistead avenue; audubon PA 19403
• Manufacturer (Section G): GLOBUS MEDICAL, INC.; 2560 general armistead avenue; audubon PA 19403
• Manufacturer Contact: daniel paul ; 2560 general armistead avenue; audubon, PA 19403 ; 6109301800
• MDR Report Key: 23595861
• Report Number: 3004142400-2025-00284
• Device Sequence Number: 21177591
• Product Code: LXH
• UDI-Device Identifier: 00849044075007
• UDI-Public: 00849044075007
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: D154976
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/19/2025

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: 639.650
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/10/2025
• Initial Report FDA Received Date: 11/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown