MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. PATRIOT SIGNATURE INSTRUMENTS; SIZER/SHAVER, 7MM

Model Number	668.507
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The part was not returned for evaluation.Due to the age of the instrument, it is possible that normal wear and tear over time contributed to the reported failure.The exact cause of the reported issue could not be determined.
Event or Problem Description
It was reported that during a surgery the instrument broke and part of it was left inside patient.This event occurred in saudi arabia.
Additional Manufacturer Narrative
The device was returned for evaluation.Initial observation shows the tip of the instrument has fractured off.It is possible that normal wear and tear over time contributed to the fracture; however, an exact cause of the reported issue could not be determined.
Event or Problem Description
It was reported that during a surgery the instrument broke and part of it was left inside patient.This event occurred in saudi arabia.

• Brand Name: PATRIOT SIGNATURE INSTRUMENTS
• Common Device Name: SIZER/SHAVER, 7MM
• 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: 15537884
• Report Number: 3004142400-2022-00152
• Device Sequence Number: 6243338
• Product Code: LXH
• UDI-Device Identifier: 00849044026580
• UDI-Public: 00849044026580
• 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: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2022

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: 668.507
• Device Lot Number: BTJ197BA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/26/2022
• Supplement Date Received by Manufacturer: 09/26/2022
• Initial Report FDA Received Date: 10/04/2022
• Supplement Report FDA Received Date: 11/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/16/2008
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Sex: Female