MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. SI-LOK; 4.0MM RETAINING HEX SIJ DRIVER

Model Number	639.650
Medical Device Problem Code	Human-Device Interface Problem (2949)
Health Effect - Clinical Code	Spinal Column Injury (2081)
Date of Event	02/26/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when the surgeon was placing a 12x40mm si-lok screw, the threads on the outer sleeve of the driver broke off in the screw head.The surgeon was unable to remove the threads and left them in the screw head.
Additional Manufacturer Narrative
This report is being resubmitted for an incident that occurred earlier.The instrument was returned for evaluation and it was confirmed that the driver tip had sheared off.It is possible the driver may have experienced excessive forces during imp!antatlondue to several causes.The bone may have been very hard or may not have been properly prepared with the appropriate drill size.Additionally, the driver hex may not have been fully seated into the screw head producing minimal engagement of 'the driver and screw.If the hex is not seated, there is no counterforce to the threaded shaft and the threaded shaft may not be axially aligned with the screw causing excessive force on the threads.However, the exact cause of the reported issue cannot be determined.

• Brand Name: SI-LOK
• Common Device Name: 4.0MM RETAINING HEX SIJ DRIVER
• 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: 18831628
• Report Number: 3004142400-2019-00023
• Device Sequence Number: 14222092
• Product Code: LXH
• UDI-Device Identifier: 00849044075007
• UDI-Public: 00849044075007
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 03/04/2024

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: 639.650
• Device Lot Number: FAV285DC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/05/2019
• Initial Report FDA Received Date: 03/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/12/2018
• 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 Age: 48 YR
• Patient Sex: Female