MAUDE Adverse Event Report: K2M, INC. LOCKING SCREW INSERTER; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	2901-90098
Medical Device Problem Codes	Corroded (1131); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Lot kcab (1): manufacture date: 30 october 2019.Device returned: 02 december 2022.Lot guyu (1): manufacture date: 30 july 2018.Device returned: 02 december 2022.Lot pgkt (1): device returned: 27 october 2022.Lot muat (1): manufacture date: 10 november 2020.Device returned 27 october 2022.Lot muat (2): manufacture date: 10 november 2020.Device not returned.Lot unknown (1): device not returned.
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 seven instances of intraoperative everest locking screw inserter deformation.
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 seven instances of intraoperative everest locking screw inserter deformation.
Additional Manufacturer Narrative
Lot kcab (1): manufacture date 30 october 2019.Device returned 02 december 2022.Lot guyu (1): manufacture date 30 july 2018.Device returned 02 december 2022.Lot pgkt (1): device returned 27 october 2022.Lot muat (1): manufacture date 10 november 2020.Device returned 27 october 2022.Lot muat (2): manufacture date 10 november 2020.Device not returned.Lot unknown (1): device not returned.

• Brand Name: LOCKING SCREW INSERTER
• 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: 16264993
• Report Number: 3004774118-2023-00009
• Device Sequence Number: 19917822
• Product Code: LXH
• UDI-Device Identifier: 10888857040564
• UDI-Public: 10888857040564
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 7
• 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
• Report Date (Section B): 04/28/2023

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: 2901-90098
• Device Catalogue Number: 2901-90098
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• 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
• Initial Report FDA Received Date: 01/30/2023
• Supplement Report FDA Received Date: 04/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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