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

Model Number	685.007
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/12/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while placing screws, the tip of (2) k-wires broke off at the distal ends and remain in the patient.
Additional Manufacturer Narrative
The device was not returned for evaluation.The imaging provided confirms the location of the broken k-wire tips near the tip of the screw.This type of damage can be consistent with excessive force/speed; however, an exact cause of the reported issue could not be determined.
Additional Manufacturer Narrative
The device was returned for evaluation.Initial observation shows that the device had fractured at the tip and is missing the threaded portion.This type of damage may have been caused from a deviation of trajectory that would cause an interference between the k-wire and instrument/implant.That interference could then place excessive force on the tip of the k-wire during removal and cause it to fracture.However, no determinations could be made as to the cause of the reported issue.
Event or Problem Description
It was reported that while placing screws, the tip of k-wires broke off at the distal ends and remain in the patient.

• Brand Name: REVOLVE
• 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: 16161396
• Report Number: 3004142400-2023-00009
• Device Sequence Number: 6067041
• 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
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2023

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
• Device Lot Number: BTA215AB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/19/2022
• Supplement Date Received by Manufacturer: 12/19/2022
• Initial Report FDA Received Date: 01/13/2023
• Supplement Report FDA Received Date: 04/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/03/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown