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	07/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr is part of the fda voluntary malfunction summary reporting program.Additional information: two (2) of the three (3) devices have been returned for analysis.Lot mmuu - received 22/jul/2021.Lot mmuu - received 22/jul/2021.Lot jpvu has not been received.A supplemental vmsr will be submitted upon completion of the investigations.
Event or Problem Description
This report summarizes three malfunction events in which everest mi provisional split drivers jammed intra-operatively.Two devices, "locked into driver and will not rotate," one device, "was not retaining the set screw," due to a jammed knob.Surgeries were successfully completed with 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.Lots# mmuu (2).Lot# jpvu - manufactured 19/jul/2019.Visual inspection: device was inspected and observed that the knob was jamming on the handle.Functional inspection: attempts to unthread/release the jammed condition were unsuccessful during functional testing.Device history records were reviewed for lot jpvu and no relevant manufacturing issues were identified.Complaint history records were reviewed and multiple events for jamming were identified for the catalog number; however, these incidents were not isolated to the subject lot number.The distal tip of the returned devices were observed to be in a closed stage.The jammed knob and closed stage of the tip 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 torquing 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 three malfunction events in which everest mi provisional split drivers jammed intra-operatively.Two devices, "locked into driver and will not rotate," one device, "was not retaining the set screw," due to a jammed knob.Surgeries were successfully completed with 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
• MDR Report Key: 12249401
• Report Number: 3004774118-2021-00233
• Device Sequence Number: 4440677
• 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: 3
• 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): 10/28/2021

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2021
• Initial Date Received by Manufacturer: 07/01/2021
• Supplement Date Received by Manufacturer: 10/01/2021
• Initial Report FDA Received Date: 07/29/2021
• Supplement Report FDA Received Date: 10/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1