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	05/24/2022
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 outer shaft/handle.
Event or Problem Description
It was reported that an aleutian an coronal inserter and outer shaft/handle were broken at the base intra-operatively.Upon further inspection of the outer shaft/handle, it was found that there were no identiifed issues with this device.There were no adverse consequences to the patient.The procedure was completed successfully without surgical delay.This report captures the outer shaft/handle.
Additional Manufacturer Narrative
Upon further inspection of the outer shaft/handle, it was found that there were no identiifed issues with this device.Report 3004774118-2022-00246 has been filed for the inserter inner shaft which fractured at the tip.

• 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: 14777590
• Report Number: 3004774118-2022-00247
• Device Sequence Number: 4896014
• 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): 09/12/2022

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: 5303-90004
• Device Catalogue Number: 5303-90004
• Device Lot Number: KYRK
• 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