MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. REVERE; SURGICAL INSTRUMENT HANDLE, TORQUE LIMITING

Model Number	634.611
Medical Device Problem Code	Human-Device Interface Problem (2949)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2025
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 due to wear and tear on the handle they had a cap back out post operatively.
Additional Manufacturer Narrative
Based on the description of the event evaluation form and follow-up email, a cap was backed out post-operatively.A revision surgery was taken place to take out failed hardware.The torque of the handle was reported to not function as normal.However, the part was not returned.Therefore, an evaluation of the physical part cannot be performed, and the exact cause cannot be established.This complaint is captured in the system's risk analysis creo 4.75mm threaded cocr deformity & degen stabilization system, creo amp 4.75mm threaded cocr deformity & degen stabilization system, creo amp threaded deformity stabilization system, creo amp threaded stabilization system, creo fenestrated mis stabilization system, creo fenestrated threaded stabilization system, creo mis stabilization system, creo nxt deformity stabilization system, creo nxt stabilization system, creo threaded deformity stabilization system, creo threaded stabilization system, revere 5.5 & 6.35 deformity ss system, and revere threaded reduction.This complaint will be re-evaluated if the part is returned at a future date.The product is within the anticipated risk; therefore, the overall risk of the system has been maintained and will continue to be monitored.The following sections were updated for this supplemental report.B4, g3, g6, h2, h6, h10.
Event or Problem Description
It was reported that due to wear and tear on the handle they had a cap back out post operatively.

• Brand Name: REVERE
• Common Device Name: SURGICAL INSTRUMENT HANDLE, TORQUE LIMITING
• 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: 23407577
• Report Number: 3004142400-2025-00264
• Device Sequence Number: 21101291
• Product Code: LXH
• UDI-Device Identifier: 00849044065978
• UDI-Public: 00849044065978
• Combination Product (Y/N): N
• 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): 12/01/2025

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: 634.611
• 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: 09/08/2025
• Supplement Date Received by Manufacturer: 12/01/2025
• Initial Report FDA Received Date: 10/28/2025
• Supplement Report FDA Received Date: 12/01/2025
• 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