MAUDE Adverse Event Report: K2M, INC. INSERTER, OUTER SHAFT/HANDLE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	5303-90004
Medical Device Problem Codes	No Apparent Adverse Event (3189); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tip of an aleutian an coronal inserter was fractured and the outer shaft/handle was broken outside the or.There were no adverse consequences to the patient.The procedure was completed successfully without surgical delay.This report captures the handle.
Additional Manufacturer Narrative
Visual, dimensional, functional and material analysis could not be performed as the device was not returned.Complaint history records were reviewed for this catalog number, similar complaints were identified.The device was not returned and is unavailable for evaluation.Photos provided show an intact outer shaft, therefore, it is likely that there is no problem with the outer shaft, and the reported fracture is only affecting the inserter.
Event or Problem Description
It was reported that the tip of an aleutian an coronal inserter was fractured and the outer shaft/handle was broken outside the or.There were no adverse consequences to the patient.The procedure was completed successfully without surgical delay.This report captures the handle.

• Brand Name: INSERTER, OUTER SHAFT/HANDLE
• 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: 14691402
• Report Number: 3004774118-2022-00236
• Device Sequence Number: 6692534
• Product Code: LXH
• UDI-Device Identifier: 10888857110489
• UDI-Public: 10888857110489
• 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): 09/09/2022

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: 5303-90004
• Device Catalogue Number: 5303-90004
• Device Lot Number: KYRK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/17/2022
• Supplement Date Received by Manufacturer: 08/12/2022
• Initial Report FDA Received Date: 06/14/2022
• Supplement Report FDA Received Date: 09/09/2022
• 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: Male