MAUDE Adverse Event Report: K2M, INC. AN LORDOTIC - OBLIQUE INSERTER; SIZE 8.5X32 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	5303-90002
Medical Device Problem Codes	Deformation Due to Compressive Stress (2889); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A company representative reported an aleutian an lordotic oblique inserter bent during implant rotation.The procedure was completed successfully with no surgical delay and no adverse consequence to the patient.
Event or Problem Description
A company representative reported an aleutian an lordotic oblique inserter bent during implant rotation.The procedure was completed successfully with no surgical delay and no adverse consequence to the patient.
Additional Manufacturer Narrative
A visual inspection was performed.The tip of the inner shaft is deformed such that one prong is bent outward.Signs of excessive use along with the laser making fading off was identified on the device.A functional inspection was performed and it was found that the device is no longer functional.Device history records were reviewed for this lot, and no relevant issues were identified.It was noted that the device was over five years old.A review of complaint history associated with the subject catalog number and lot number was performed.No adverse trends were observed.Initial report states that an aleutian an lordotic oblique inserter inner shaft tip deformed intra-operatively during implant rotation at l4-5 level.The implant was left in the patient.Per the sales representative, position of the implant markers is unknown.The disc space was tight and the surgeon appeared to use excessive force on the device during the procedure.The device ifu and surgical technique were reviewed: ¿ensure the orientation references on the implant are properly aligned with those on the inserter.¿ note: ¿there are anatomic orientation references on the two inserter components.Ensure these are properly aligned during assembly as designated in the image in the surgical technique.¿ the most likely cause of the reported event was determined to be multi-factorial.Factors such as the application of excessive torque during implant rotation, improper alignment of the implant with the inserter, tight disc space and normal wear likely all contributed to the tip deformation.

• Brand Name: AN LORDOTIC - OBLIQUE INSERTER; SIZE 8.5X32 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: 13581307
• Report Number: 3004774118-2022-00070
• Device Sequence Number: 14873174
• Product Code: LXH
• UDI-Device Identifier: 10888857110465
• UDI-Public: 10888857110465
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2022

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: 5303-90002
• Device Lot Number: FAMT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/24/2022
• Supplement Date Received by Manufacturer: 04/28/2022
• Initial Report FDA Received Date: 02/22/2022
• Supplement Report FDA Received Date: 05/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/18/2017
• 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: Male