MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CORRIDOR; 1.05MM K-WIRE X 600MM, BLUNT TIP, NITINOL

Model Number	648.005
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The remaining device was not available for evaluation as it was discarded by the hospital.It is possible that the k-wire was impinged by the screw and broke upon insertion or removal; however, the exact cause of the reported issue could not be determined.
Event or Problem Description
It was reported by a representative from germany that the tip of the k-wire broke and was left inside the patient.

• Brand Name: CORRIDOR
• Common Device Name: 1.05MM K-WIRE X 600MM, BLUNT TIP, NITINOL
• Manufacturer (Section D): GLOBUS MEDICAL, INC.; 2560 general armistead avenue; audubon 19403
• MDR Report Key: 11440371
• Report Number: 3004142400-2021-00042
• Device Sequence Number: 3997734
• Product Code: LXH
• UDI-Device Identifier: 00889095152012
• UDI-Public: 00889095152012
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: D368745
• 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): 03/05/2021

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: 648.005
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/09/2021
• Initial Report FDA Received Date: 03/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other