MAUDE Adverse Event Report: K2M, INC. AN LORDOTIC - OBLIQUE INSERTER; SIZE 8.5X28 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	5303-90001
Medical Device Problem Codes	Fracture (1260); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during set reassembly outside the or, the knob of an aleutian an coronal inserter outer shaft/handle and inserter was jammed.There was no associated procedure with this event, therefore, no adverse consequences to any patients were seen.This report captures the inserter.
Additional Manufacturer Narrative
The event was originally reported as a device jam, but based on device evaluation this has been corrected to device fracture.Upon inspection of the returned device, it was observed that the tip of the inserter was fractured.All other h6 coding has been updated to reflect device evaluation and investigation conclusion.
Event or Problem Description
It was reported that during set reassembly outside the or, the knob of an aleutian an coronal inserter outer shaft/handle and inserter was jammed.There was no associated procedure with this event, therefore, no adverse consequences to any patients were seen.This report captures the inserter.Upon inspection of the returned device, it was observed that the tip of the inserter was fractured.

• Brand Name: AN LORDOTIC - OBLIQUE INSERTER; SIZE 8.5X28 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: 14932829
• Report Number: 3004774118-2022-00259
• Device Sequence Number: 15179731
• Product Code: LXH
• UDI-Device Identifier: 10888857110458
• UDI-Public: 10888857110458
• Combination Product (Y/N): N
• Initial Reporter State: ME
• 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): 09/29/2022

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: 5303-90001
• Device Catalogue Number: 5303-90001
• Device Lot Number: DGKY
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/08/2022
• Supplement Date Received by Manufacturer: 09/02/2022
• Initial Report FDA Received Date: 07/06/2022
• Supplement Report FDA Received Date: 09/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/03/2015
• 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