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

Catalog Number 5303-90002

Device Problems Deformation Due to Compressive Stress (2889); Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/24/2022

Event Type  malfunction  

Event 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 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.

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
• Type of Device: 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
• MDR Text Key: 288103261
• Report Number: 3004774118-2022-00070
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 10888857110465
• UDI-Public: 10888857110465
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 01/24/2022
• Initial Date FDA Received: 02/22/2022
• Supplement Dates Manufacturer Received: 04/28/2022
• Supplement Dates FDA Received: 05/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/18/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Sex: Male