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

Model Number 685.007

Device Problem Material Fragmentation (1261)

Patient Problem Spinal Column Injury (2081)

Event Date 02/16/2024

Event Type  malfunction  

Event Description

It was reported that during a case the tip of the k-wire broke off and was retained in the patient post operatively.This event occurred in austria.

Manufacturer Narrative

The device was not available for evaluation.It was reported that during a case the tip of the k-wire broke off and was retained in the patient post operatively.An evaluation of the part could not be completed as the part was not returned.No determination could be made as to the cause of the reported issue.

• Brand Name: N/A
• 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: 18888336
• MDR Text Key: 337558547
• Report Number: 3004142400-2024-00052
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 00849044072105
• UDI-Public: 00849044072105
• 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
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/12/2024

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
• Device Operator: Health Professional
• Device Model Number: 685.007
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/16/2024
• Initial Date FDA Received: 03/12/2024
• 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