MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CITADEL; SCREWDRIVER SHAFT, 3.5MM HEX, 1/4 INCH QC, SELF-RETAINING

Model Number	630.414
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The tip of the driver has sheared off due to excessive torque.The cause of the reported issue is likely excessive force.
Event or Problem Description
It was reported that the tip of the screwdriver broke off in the screw and remains in the patient.

• Brand Name: CITADEL
• Common Device Name: SCREWDRIVER SHAFT, 3.5MM HEX, 1/4 INCH QC, SELF-RETAINING
• Manufacturer (Section D): GLOBUS MEDICAL, INC.; 2560 general armistead avenue; audubon 19403
• MDR Report Key: 11232672
• Report Number: 3004142400-2021-00014
• Device Sequence Number: 19616058
• Product Code: LXH
• UDI-Device Identifier: 00849044037524
• UDI-Public: 00849044037524
• Combination Product (Y/N): N
• 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
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/22/2021

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: 630.414
• Device Lot Number: FAX059GF
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/30/2020
• Initial Report FDA Received Date: 01/26/2021
• 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