MAUDE Adverse Event Report: K2M, INC. 3-SCREW DRILL GUIDE INSERTER; SIZE 8 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	3608-90031
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/11/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that three (3) chesapeake cervical ti 3-screw drill guide inserters could no longer hold implants intra-operatively.The surgery was completed successfully.No adverse consequences, surgical delay or medical intervention were reported.This report captures the second of three drill guide inserters.
Additional Manufacturer Narrative
H6 codes have been updated to reflect receipt of the device and conclusion of the investigation.
Event or Problem Description
It was reported that three (3) chesapeake cervical ti 3-screw drill guide inserters could no longer hold implants intra-operatively.The surgery was completed successfully.No adverse consequences, surgical delay or medical intervention were reported.This report captures the second of three drill guide inserters.

• Brand Name: 3-SCREW DRILL GUIDE INSERTER; SIZE 8 MM
• 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: 15186783
• Report Number: 3004774118-2022-00320
• Device Sequence Number: 20486294
• Product Code: LXH
• UDI-Device Identifier: 10888857082557
• UDI-Public: 10888857082557
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2022

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 Model Number: 3608-90031
• Device Catalogue Number: 3608-90031
• Device Lot Number: GRCN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/11/2022
• Supplement Date Received by Manufacturer: 10/07/2022
• Initial Report FDA Received Date: 08/08/2022
• Supplement Report FDA Received Date: 11/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/26/2018
• 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