MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO MIS; 4.5MM CANNULATED TAP

Model Number	6134.0045
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is being resubmitted for an incident that occurred earlier.Evaluation found the distal tip of the instrument has sheared off and there are signs of fatigue and metal deformation.It is possible that the tap was off axis with the k-wire and caused the wire to kink around the tip of the tap.This would cause forces to be applied radially outward on the cannulation, causing the tip to deform.The exact cause of the reported issue could not be determined.
Event or Problem Description
It was reported that during surgery the tip of a cannulated tap sheared off and left fragments in the patient.The fragments were recovered during a revision surgery.

• Brand Name: CREO MIS
• Common Device Name: 4.5MM CANNULATED 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: 18832865
• Report Number: 3004142400-2019-00007
• Device Sequence Number: 7457646
• Product Code: LXH
• UDI-Device Identifier: 00889095178104
• UDI-Public: 00889095178104
• 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): 03/04/2024

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
• Operator of Device: Health Professional
• Device Model Number: 6134.0045
• Device Lot Number: TLT342BA
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/17/2019
• Initial Report FDA Received Date: 03/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/07/2016
• 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: 50 YR
• Patient Sex: Male
• Patient Race: Black Or African American