MAUDE Adverse Event Report: K2M, INC. OCCIPITAL DRILL GUIDE; SIZE (10/12); ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	1101-90062
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the occipital straight drill got stuck in the occipital drill guide while drilling the first hole.No adverse consequences, or medical intervention were reported. the procedure was completed successfully with another device and a 120 minute surgical delay.This report will capture the occipital drill guide.
Additional Manufacturer Narrative
Updated b5 to reflect confirmed length of surgical delay.Initial report suggested the length of surgical delay was 120 minutes.Upon further review of the reported event and information provided by the field, it has been confirmed the surgical delay was 10 minutes.As the event did not result in a prolonged surgical delay, this event is no longer reportable as no death or serious deterioration in state of health of a patient, user, or other person has occurred or is likely to occur.
Event or Problem Description
It was reported that the occipital straight drill got stuck in the occipital drill guide while drilling the first hole.No adverse consequences nor medical intervention were reported. the procedure was completed successfully with a 10 minute surgical delay.This report will capture the occipital drill guide.

• Brand Name: OCCIPITAL DRILL GUIDE; SIZE (10/12)
• 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: 12598767
• Report Number: 3004774118-2021-00312
• Device Sequence Number: 3473725
• Product Code: LXH
• UDI-Device Identifier: 10888857017061
• UDI-Public: 10888857017061
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 01/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 1101-90062
• Device Lot Number: NKMA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/13/2021
• Supplement Date Received by Manufacturer: 12/29/2021
• Initial Report FDA Received Date: 10/08/2021
• Supplement Report FDA Received Date: 01/24/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown