MAUDE Adverse Event Report: K2M, INC. GRAFT CONTAINMENT RAMP, W/ADAPTER; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	3201-90293
Medical Device Problem Codes	Fracture (1260); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/29/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that two aleutian graft containment ramps were bent and broken intra-operatively.Surgery was successfully completed with no delay.No adverse consequences or medical intervention were reported.This record will capture the second of two ramps.
Event or Problem Description
It was reported that two aleutian graft containment ramps were bent and broken intra-operatively.Surgery was successfully completed with no delay.No adverse consequences or medical intervention were reported.This record will capture the second of two ramps.
Additional Manufacturer Narrative
The tip of the graft ramp was observed to be bent and deformed.Complaint history records were reviewed for this catalog and no similar complaints were identified.No further information was received from the field.Based on the deformation of the device, the likely cause is excessively applied cantilever force.

• Brand Name: GRAFT CONTAINMENT RAMP, W/ADAPTER
• 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: 13047765
• Report Number: 3004774118-2021-00409
• Device Sequence Number: 3912507
• Product Code: LXH
• UDI-Device Identifier: 10888857059313
• UDI-Public: 10888857059313
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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): 04/01/2022

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: 3201-90293
• Device Catalogue Number: 3201-90293
• Device Lot Number: PFJY
• 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: 11/29/2021
• Supplement Date Received by Manufacturer: 03/09/2022
• Initial Report FDA Received Date: 12/20/2021
• Supplement Report FDA Received Date: 04/01/2022
• 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
• Patient Sex: Unknown