MAUDE Adverse Event Report: GLOBUS MEDICAL, INC.; 5.5MM TAP

Model Number	655.215
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a surgery that the threaded tip of the tap was broken and remains in the patient pedicle post operatively.
Additional Manufacturer Narrative
The device was not returned for evaluation.It was reported that the 5.5mm tap tip fractured and was left in the patient on (b)(6) 2024.The case was stated to be a revision case with creo threaded pedicle screws placed at l4-s2ai and one tlif interbody device.It was stated that the tap was used to create the pathway for the screw, consistent with the procedural steps specified in the technique guide.It cannot be confirmed what forces were placed on the tap that may have caused a fracture because surgical conditions cannot be replicated.No determinations could be made as to the cause of the reported issue.

• Common Device Name: 5.5MM TAP
• 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: 19518233
• Report Number: 3004142400-2024-00107
• Device Sequence Number: 6425176
• Product Code: LXH
• UDI-Device Identifier: 00849044026269
• UDI-Public: 00849044026269
• 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: 2024
• 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): 06/07/2024

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: 655.215
• Device Lot Number: BTW192HA
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/16/2024
• Initial Report FDA Received Date: 06/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/11/2019
• 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: 45 YR
• Patient Sex: Female