MAUDE Adverse Event Report: K2M, INC. PROVISIONAL SPLIT DRIVER; SIZE 30; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	5101-90129
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr is part of the fda voluntary malfunction summary reporting program.A supplemental vmsr will be submitted upon completion of the investigation.
Event or Problem Description
This report summarizes one malfunction event where the handle of an everest mi provisional split driver "jammed" intra-operatively.Surgery was successfully completed with another driver and no delay.No adverse consequences or medical intervention were reported.
Additional Manufacturer Narrative
This mdr is part of the fda voluntary malfunction summary reporting program.Visual inspection: device was inspected and observed that the knob was jamming on the handle.Functional inspection: higher force was used to unthread the knob from the handle, but it was not successful.Complaint history records were reviewed for this lot and no similar complaints were identified.Similar complaints for the catalog were reported among different lot numbers.The jammed knob implies that the user torqued the knob more than needed in the clockwise direction.The use of this instrument is defined to grab and place set screws.Any other deviations such as over torqueing the knob (clockwise or anti-clockwise) would result in internal jamming of the instrument; therefore, the plausible root cause has been identified as user error.
Event or Problem Description
This report summarizes one malfunction event where the handle of an everest mi provisional split driver "jammed" intra-operatively.Surgery was successfully completed with another driver and no delay.No adverse consequences or medical intervention were reported.

• Brand Name: PROVISIONAL SPLIT DRIVER; SIZE 30
• 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: 12723555
• Report Number: 3004774118-2021-00338
• Device Sequence Number: 14523594
• Product Code: LXH
• UDI-Device Identifier: 10888857210141
• UDI-Public: 10888857210141
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2022

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 Catalogue Number: 5101-90129
• Device Lot Number: NHFH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/01/2021
• Supplement Date Received by Manufacturer: 01/01/2022
• Initial Report FDA Received Date: 10/29/2021
• Supplement Report FDA Received Date: 01/25/2022
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown