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

Model Number 685.007

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Insufficient Information (4580)

Event Date 01/22/2019

Event Type  malfunction  

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 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.

• Type of Device: 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
• MDR Text Key: 336748789
• Report Number: 3004142400-2019-00010
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: D154976
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/29/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 685.007
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/23/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 42 YR
• Patient Sex: Female
• Patient Race: White