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

Catalog 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	10/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr is part of the fda voluntary malfunction summary reporting program.Visual inspection: the returned everest locking screw inserter was visually and functionally inspected.The instrument arrived fully assembled.The tip of the device was observed to be fractured, with little hex pattern remaining.The instrument was disassembled.The outer shaft, containing the locking mechanism, was very visibly worn, while the inner shaft, containing the tip, appeared to have no visible signs of use.Functional inspection: with the locking mechanism in the unlocked position, the inner shaft was able to spin freely.The knob of the locking mechanism was attempted to be pulled upwards to move to the 'locked' position, but was jammed halfway between the two options.The knob was unable to return to the locked position with normal force.Complaint history records were reviewed for this lot, and 3 similar complaints were identified.The reported event of a tip deformation/fracture could occur due to consistent use of the device throughout its lifetime, excessive torsional or axial force utilized on the instrument, use of the device against the surgical technique guide, or patient factors contributing to fatigue on the instrument.Therefore, the root cause of the reported event cannot be conclusively determined at this time.
Event or Problem Description
This report summarizes one malfunction event where the tip of everest locking screw inserter "stripped" intra-operatively.Surgery was successfully completed with another driver and no delay.No adverse consequences or medical intervention were reported.

• Brand Name: LOCKING SCREW INSERTER
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 12723442
• Report Number: 3004774118-2021-00339
• Device Sequence Number: 19904069
• 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
• Report Date (Section B): 10/29/2021

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: HRGP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/01/2021
• Initial Report FDA Received Date: 10/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1