MAUDE Adverse Event Report: K2M, INC. PROVISIONAL SPLIT DRIVER; SIZE 30; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	5101-90129
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
This record is a consolidation of q4 2022 records summarized as a part of the fda voluntary malfunction summary reporting program.This report captures three instance of intraoperative everest mi provisional split driver jamming.
Additional Manufacturer Narrative
Lot kjdy (1): manufacture date 23 december 2019.Device returned 27 october 2022.Lot unknown (2): device not returned.
Additional Manufacturer Narrative
Lot kjdy (1): manufacture date 23 december 2019.Device returned 27 october 2022.Lot nxjh (2): device returned 20 february 2023.
Event or Problem Description
This record is a consolidation of q4 2022 records summarized as a part of the fda voluntary malfunction summary reporting program.This report captures three instance of intraoperative everest mi provisional split driver jamming.
Additional Manufacturer Narrative
Lot kjdy (1): manufacture date 23 december 2019.Device returned 27 october 2022.Lot nxjh (2): manufacture date 25 march 2021.Device returned 20 february 2023.
Event or Problem Description
This record is a consolidation of q4 2022 records summarized as a part of the fda voluntary malfunction summary reporting program.This report captures three instance of intraoperative everest mi provisional split driver jamming.

• Brand Name: PROVISIONAL SPLIT DRIVER; SIZE 30
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• Manufacturer (Section G): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• Manufacturer Contact: rita karan ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 16265122
• Report Number: 3004774118-2023-00010
• Device Sequence Number: 17243964
• Product Code: LXH
• UDI-Device Identifier: 10888857210141
• UDI-Public: 10888857210141
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 3
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/26/2023

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: 5101-90129
• Device Catalogue Number: 5101-90129
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/01/2023
• Supplement Date Received by Manufacturer: 04/01/2023; 07/01/2023
• Initial Report FDA Received Date: 01/30/2023
• Supplement Report FDA Received Date: 04/28/2023; 07/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown