MAUDE Adverse Event Report: K2M, INC. INSERTER THREADED SHAFT; SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Model Number	2112-90009
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/24/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A company representative reported that a capri inserter, capri inserter inner shaft, and capri non-tapered driver were damaged during surgery.The surgeon malleted the inserter into the patient which caused deformation on the proximal end of the capri inserter (mallet marks) and deformation on the distal end of the capri inserter inner shaft.Images provided indicate the distal end of the capri non-tapered driver is also deformed.The procedure was completed successfully with no surgical delay and no adverse consequence to the patient.This record captures the capri inserter inner shaft.
Event or Problem Description
A company representative reported that a capri inserter, capri inserter inner shaft, and capri non-tapered driver were damaged during surgery.The surgeon malleted the inserter into the patient which caused deformation on the proximal end of the capri inserter (mallet marks) and deformation on the distal end of the capri inserter inner shaft.Images provided indicate the distal end of the capri non-tapered driver is also deformed.The procedure was completed successfully with no surgical delay and no adverse consequence to the patient.This record captures the capri inserter inner shaft.
Additional Manufacturer Narrative
A visual inspection was performed on the device and the reported issue of inserter damage and inserter inner shaft damage was confirmed.The proximal end of the inserter and the inserter inner shaft exhibits severe mallet marks indicating that excessive force was applied to these devices during implant insertion.A review of complaint history associated with the subject catalog and lot number was performed, and no adverse trend was observed.The device was inspected prior to the procedure and no damage was noticed.Hence, the cause of the reported event is application of excessive force by the user causing device deformation.

• Brand Name: INSERTER THREADED SHAFT
• Common Device Name: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
• 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: 14780540
• Report Number: 3004774118-2022-00250
• Device Sequence Number: 5936413
• Product Code: MQP
• UDI-Device Identifier: 10888857033665
• UDI-Public: 10888857033665
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K142016
• 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): 09/15/2022

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: 2112-90009
• Device Catalogue Number: 2112-90009
• Device Lot Number: KHCG
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/24/2022
• Supplement Date Received by Manufacturer: 08/19/2022
• Initial Report FDA Received Date: 06/22/2022
• Supplement Report FDA Received Date: 09/15/2022
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown