MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. RISE; LATERAL TORQUE LIMITING DRIVER, 3.0NM

Model Number	693.600
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/06/2020
Type of Reportable Event	Malfunction
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.The tip is made from stainless steel which has a history of biocompatibility.The combination of stainless steel and the titanium implant material does not present a corrosion concern.It is possible repeated stress from torqueing the driver multiple times successively contributed to the observe_d damage.However, the exact cause of the reported issue cannot be determined.
Event or Problem Description
It was reported the tip of the lateral torque limiting driver broke off in the expansion screw of an elsa spacer.The instrument tip was unable to be retrieved.

• Brand Name: RISE
• Common Device Name: LATERAL TORQUE LIMITING DRIVER, 3.0NM
• 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: molly moneypenny ; 2560 general armistead avenue; audubon, PA 19403 ; 6109301800
• MDR Report Key: 18823389
• Report Number: 3004142400-2020-00027
• Device Sequence Number: 20636685
• Product Code: LXH
• UDI-Device Identifier: 00889095058451
• UDI-Public: 00889095058451
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/02/2024

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
• Operator of Device: Health Professional
• Device Model Number: 693.600
• Device Lot Number: BRV200KB
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/11/2020
• Initial Report FDA Received Date: 03/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/19/2018
• 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: 77 YR
• Patient Sex: Female