MAUDE Adverse Event Report: GLOBUS MEDICAL, INC.; 1.6MM NITINOL K-WIRE, 500MM, BLUNT TIP

Model Number	685.007
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The k-wire was not available for evaluation as it was discarded by the hospital.It's possible contributing factors of the breakage could be variations in wire insertion angle, tap trajectory, and screw insertion trajectory.However, the exact cause of the reported issue cannot be determined.
Event or Problem Description
During the process of tapping right s1 pedicle, the tip of the guide wire (685.007) broke off and was left in the patient.
Additional Manufacturer Narrative
This report is being resubmitted for an incident that occurred earlier.The k-wire was not available for evaluation as it was discarded by the hospital.It's possible contributing factors of the breakage could be variations in wire insertion angle, tap trajectory, and screw insertion trajectory.However, the exact cause of the reported issue cannot be determined.
Event or Problem Description
During the process of tapping right s1 pedicle, the tip of the guide wire (685.007) broke off and was left in the patient.

• Common Device Name: 1.6MM NITINOL K-WIRE, 500MM, BLUNT TIP
• 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: 18809992
• Report Number: 3004142400-2019-00010
• Device Sequence Number: 20640760
• Product Code: LXH
• UDI-Device Identifier: 00849044072105
• UDI-Public: 00849044072105
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2024

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: 685.007
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/23/2019
• Supplement Date Received by Manufacturer: 01/23/2019
• Initial Report FDA Received Date: 02/29/2024
• Supplement Report FDA Received Date: 03/01/2024
• 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 Age: 42 YR
• Patient Sex: Female
• Patient Race: White