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

Model Number	639.008
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was unavailable for evaluation.No determinations could be made as to the cause of the reported issue.
Event or Problem Description
It was reported that a wire was called for by surgeon for pelvic case; bent wire prior to inserting.The wire was sent in and as a cannulated drill went over it for pre drilling, wire broke.About 50-70mm of wire was unable to be removed from patient.
Event or Problem Description
It was reported that a wire was called for by surgeon for pelvic case; bent wire prior to inserting.The wire was sent in and as a cannulated drill went over it for pre drilling, wire broke.About 50-70mm of wire was unable to be removed from patient.
Additional Manufacturer Narrative
The part was not returned for evaluation.Dhr records could not be evaluated.The eef indicated there were no adverse events to the patient.A risk evaluation was conducted (above) and it was found that the observed risk level (low) is within the expected risk level (low).The rep was contacted for additional information and confirmed that the surgeon bent the relevant k-wire before the case.This action may have influenced the noted complaint.Since the observed risk is within the expected risk level, no further actions will be taken at this time.No further evaluation was possible.This evaluation will be reopened if more information becomes available.Based on the evaluation and available information, no cause can be established.The following sections were updated for this supplemental report.B4, g6, h2, h6, h10.

• Brand Name: SI-LOK
• Common Device Name: SURGICAL DRILL GUIDE, 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: 23407580
• Report Number: 3004142400-2025-00263
• Device Sequence Number: 13030681
• Product Code: LXH
• UDI-Device Identifier: 00889095150568
• UDI-Public: 00889095150568
• Combination Product (Y/N): N
• 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,Followup
• Report Date (Section B): 11/20/2025

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: 639.008
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/25/2025
• Supplement Date Received by Manufacturer: 07/25/2025
• Initial Report FDA Received Date: 10/28/2025
• Supplement Report FDA Received Date: 11/20/2025
• 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