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

Model Number	5303-90004
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during set reassembly outside the or, the knob of an aleutian an coronal inserter outer shaft/handle and inserter was jammed.There was no associated procedure with this event, therefore, no adverse consequences to any patients were seen.This report captures outer shaft/handle.
Event or Problem Description
It was reported that during set reassembly outside the or, the knob of an aleutian an coronal inserter outer shaft/handle and inserter was jammed.There was no associated procedure with this event, therefore, no adverse consequences to any patients were seen.This report captures outer shaft/handle.
Additional Manufacturer Narrative
H6 coding has been updated to reflect device evaluation and investigation conclusion.

• 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: 14932701
• Report Number: 3004774118-2022-00258
• Device Sequence Number: 17485952
• 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): 09/29/2022

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: DGYY
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/08/2022
• Supplement Date Received by Manufacturer: 09/02/2022
• Initial Report FDA Received Date: 07/06/2022
• Supplement Report FDA Received Date: 09/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/16/2015
• 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