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

Model Number	639.650
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/14/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the threaded tip of a si-lok driver was left in the patient after it broke during surgery.
Additional Manufacturer Narrative
The si-lok driver was returned for evaluation.The threaded portion was reported to have sheared off and was left inside the screw head within the patient.It was discovered that the user of the device may have been unfamiliar with the left-handed threads on the si-lok driver and was used to the right-handed threads.When attempting to remove the driver from the implant by rotating the outer sleeve counter-clockwise, it is likely that the part was being tightened even further.Excessive force could cause the threaded portion to shear off, however, an exact cause of the reported issue could not 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 ; 6109301822
• MDR Report Key: 12855881
• Report Number: 3004142400-2021-00222
• Device Sequence Number: 14908993
• 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
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/16/2021

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: 639.650
• Device Lot Number: FAV285DC
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/27/2021
• Initial Report FDA Received Date: 11/22/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/12/2018
• 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 Age: 79 YR
• Patient Sex: Female
• Patient Weight: 91 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White