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

Model Number	5303-90002
Medical Device Problem Codes	Fracture (1260); Insufficient Device Problem Information (3190)
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
It was reported that an aleutian an coronal inserter and outer shaft/handle were broken at the base intra-operatively.There were no adverse consequences to the patient.The procedure was completed successfully without surgical delay.This report captures the inserter.
Additional Manufacturer Narrative
The device was inspected and it was confirmed that the tip of the inserter, which engages to the outer shaft internal threads, was fractured.Complaint history records were reviewed for this catalog number, no adverse trends were identified.The cause of the reported event is most likely multifactorial.The sales representative confirmed that the surgeon used excessive force on this device during the procedure, which likely contributed to the tip fracture of the device.They also confirmed that this device has been used for at least 3 years, so normal wear also could have contributed to the tip fracture as well.
Event or Problem Description
It was reported that an aleutian an coronal inserter and outer shaft/handle were broken at the base intra-operatively.There were no adverse consequences to the patient.The procedure was completed successfully without surgical delay.This report captures the inserter.

• 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: 14777589
• Report Number: 3004774118-2022-00246
• Device Sequence Number: 4896013
• 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
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2022

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: 5303-90002
• Device Catalogue Number: 5303-90002
• Device Lot Number: PHTG
• 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: 09/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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