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

Model Number	2901-90098
Medical Device Problem Codes	Fracture (1260); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
This record is a consolidation of q3 2022 records summarized as a part of the fda voluntary malfunction summary reporting program.This report captures three instances of intraoperative everest locking screw inserter deformation.The associated procedures were completed successfully with no surgical delay and no adverse consequence to a patient.
Additional Manufacturer Narrative
Lot dudwa (1): device returned 30 august 2022.Lot fmkk (1): device returned 30 august 2022.Lot kcac (1): manufacture date 16 january 2020.Device returned 25 july 2022.
Additional Manufacturer Narrative
Lot dudwa (1): manufacture date 05 october 2015.Device returned 30 august 2022.Lot kcac (1): manufacture date 16 january 2020.Device returned 30 august 2022.Lot kcac (1): manufacture date 16 january 2020.Device returned 25 july 2022.
Event or Problem Description
This record is a consolidation of q3 2022 records summarized as a part of the fda voluntary malfunction summary reporting program.This report captures three instances of intraoperative everest locking screw inserter deformation.The associated procedures were completed successfully with no surgical delay and no adverse consequence to a patient.

• 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: 15694260
• Report Number: 3004774118-2022-00367
• Device Sequence Number: 6801589
• Product Code: LXH
• UDI-Device Identifier: 10888857040564
• UDI-Public: 10888857040564
• 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
• Report Date (Section B): 01/19/2023

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): Initial
• Initial Date Received by Manufacturer: 10/01/2022
• Supplement Date Received by Manufacturer: 01/01/2023
• Initial Report FDA Received Date: 10/28/2022
• Supplement Report FDA Received Date: 01/19/2023
• 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