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

Catalog Number	2901-90098
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Lot pgkt (1): returned 16 february 2022.The investigation is still in process; we will communicate our findings in a follow-up report.
Event or Problem Description
This record is a consolidation of q1 2022 records summarized as a part of the fda voluntary malfunction summary reporting program.This report captures one instance of intraoperative everest locking screw inserter tip deformation.The procedure was completed successfully with no surgical delay and no adverse consequence to the patient.
Additional Manufacturer Narrative
Lot hfjf (1): the returned device was visually inspected.The hexalobe tip of the device was confirmed to be damaged, with the male hex features flattened and deformed in a slight counter-clockwise pattern.The instrument was disassembled and a foreign contaminant was observed on the threading of the outer shaft and the surface of the inner shaft.The teeth component at the proximal end of the inner shaft was also observed to be deformed.Device history records were reviewed and no relevant manufacturing issues were identified.Complaint history for the reported lot number was reviewed and no adverse trends were identified.The most likely root cause for the tip deformation can be attributed to normal device wear over time, as the instrument has been in the field for over 3 years prior to the reported event.Factors such as consistent use of the instrument throughout its lifetime may cause fatigue, leading to the eventual wear of the hexalobe tip.
Event or Problem Description
This record is a consolidation of q1 2022 records summarized as a part of the fda voluntary malfunction summary reporting program.This report captures one instance of intraoperative everest locking screw inserter tip deformation.The procedure was completed successfully with no surgical delay and no adverse consequence to the 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: 14254547
• Report Number: 3004774118-2022-00163
• Device Sequence Number: 17351921
• Product Code: LXH
• UDI-Device Identifier: 10888857040564
• UDI-Public: 10888857040564
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/27/2022

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 Catalogue Number: 2901-90098
• Device Lot Number: HFJF
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/01/2022
• Supplement Date Received by Manufacturer: 07/01/2022
• Initial Report FDA Received Date: 04/29/2022
• Supplement Report FDA Received Date: 07/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/26/2018
• 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