MAUDE Adverse Event Report: K2M, INC. PLATE HOLDER, THORACOLUMBAR; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	1208-90007
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A company representative reported that a cayman plate holder was not holding the plate "properly." the procedure was completed successfully with no surgical delay and no adverse consequence to the patient.
Event or Problem Description
A company representative reported that a cayman plate holder was not holding the plate "properly." the procedure was completed successfully with no surgical delay and no adverse consequence to the patient.
Additional Manufacturer Narrative
A visual inspection was performed and there appeared to be no notable damage or deformation on the tip that would have caused the event.The device was functionally tested with a sample plate and it was able to release and hold the implant without any mechanical issues arising.As the device was able to perform its intended function the reported event was unable to be replicated.Device history records were reviewed for the corresponding lot and no relevant manufacturing issues were identified.A review of complaint history associated with the subject lot and catalog number was performed and no adverse trends were observed.Limited information regarding the event was made available to stryker.Multiple attempts were made to obtain additional information, but no response was received.Based on the inspection of the device it is most likely that the surgeon in this case misassembled the device during surgery which led to the device not holding the plate properly.

• Brand Name: PLATE HOLDER, THORACOLUMBAR
• 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: 13934721
• Report Number: 3004774118-2022-00115
• Device Sequence Number: 20055299
• Product Code: LXH
• UDI-Device Identifier: 10888857019645
• UDI-Public: 10888857019645
• 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): 06/23/2022

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 Catalogue Number: 1208-90007
• Device Lot Number: AEET
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/01/2022
• Supplement Date Received by Manufacturer: 05/26/2022
• Initial Report FDA Received Date: 03/29/2022
• Supplement Report FDA Received Date: 06/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/05/2010
• 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