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

Catalog Number	2901-90098
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr is part of the fda voluntary malfunction summary reporting program.A supplemental vmsr will be submitted upon completion of investigation.
Event or Problem Description
This report summarizes 1 malfunction event where an everest spinal system locking screw inserter jammed intra-operatively.Surgery was successfully completed with a 15-20 minute delay.No adverse consequences or medical intervention were reported.
Additional Manufacturer Narrative
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Visual inspection: the main body of the instrument had signs of consistent use and normal wear.It was observed that the distal tip of the inner shaft (hexalobe tip) was not returned; therefore, functional inspection could not be performed.Device and complaint history records were reviewed, and five (5) similar complaints were identified.No relevant manufacturing issues were identified.Since the hexalobe tip of the inserter was not returned with the instrument, the root cause of the failure mode could not be determined.Ensuring that the screw is securely engaged in the inserter tip can assist in distributing forces evenly throughout the screw/inserter interface and reduce torque overloading.
Event or Problem Description
This report summarizes 1 malfunction event where an everest spinal system locking screw inserter jammed intra-operatively.Surgery was successfully completed with a 15-20 minute 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: 10350530
• Report Number: 3004774118-2020-00158
• Device Sequence Number: 14061453
• 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): 10/29/2020

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: FMKK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2020
• Initial Date Received by Manufacturer: 07/01/2020
• Supplement Date Received by Manufacturer: 10/01/2020
• Initial Report FDA Received Date: 07/31/2020
• Supplement Report FDA Received Date: 10/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1