MAUDE Adverse Event Report: K2M, INC. SCREW INSERTER; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	7601-90003
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
Event or Problem Description
This report summarizes two malfunction events where the tips of yukon oct screw inserter jammed intra-operatively.Surgeries were successfully completed; one procedure experienced a 20 second delay.No adverse consequences or medical intervention were reported.
Additional Manufacturer Narrative
This mdr is part of the fda voluntary malfunction summary reporting program.Additional information: lot kdjr - received 9/sep/2021, lot jjap.One (1) of the two (2) devices have been returned for analysis.A supplemental vmsr will be submitted upon completion of the investigations.
Additional Manufacturer Narrative
This mdr is part of the fda voluntary malfunction summary reporting program.Additional information: lot jjap - manufacturing date 30/jul/2019 - not returned.Visual, dimensional, functional and material analysis could not be performed as the device was not returned.Device and complaint history records were reviewed for this lot, and no relevant manufacturing issues or similar complaints were identified.Per additional correspondence with the rep, the device was not used at a difficult angle, excess forces were not applied on the device, device has been used about 15 times for 3 months, patient's bone quality was reported to be 'standard'.Since the device was not returned, an exact cause of the reported event cannot be determined.It is possible that patient anatomy played a factor during surgery.Shallow trajectories can have challenges as patient anatomy can make it difficult for the inserter to be coaxial with the screw, preventing proper alignment for disengagement.Lot kdjr - visual inspection: no deformities or abnormalities were observed upon receipt.Functional inspection: we were able to replicate the jamming during functional testing when the inserter was disengaged at an angle.However, if the inserter is backed out a half a turn and if the inserter tip is coaxial with the screw hexalobe, then the inserter can be disengaged.Complaint history records were reviewed for this lot, and no similar complaints were identified.It is possible that patient anatomy played a factor during surgery.Shallow trajectories can have challenges as patient anatomy can make it difficult for the inserter to be coaxial with the screw, preventing proper alignment for disengagement.However, as we were unable to replicate the failure consistently during functional testing, the root cause could not be determined conclusively.Torsional forces can allow the inserter to bind to the screw during insertion.To lessen the torsional pressure, the inserter should be backed out a half a turn.Subsequently, the user should ensure that the inserter tip is coaxial with the screw hexalobe in order to disengage the inserter.
Event or Problem Description
This report summarizes two malfunction events where the tips of yukon oct screw inserter jammed intra-operatively.Surgeries were successfully completed; one procedure experienced a 20 second delay.No adverse consequences or medical intervention were reported.

• Brand Name: SCREW INSERTER
• 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: 12721197
• Report Number: 3004774118-2021-00332
• Device Sequence Number: 1364108
• Product Code: LXH
• UDI-Device Identifier: 10888857352605
• UDI-Public: 10888857352605
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 2
• 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: 7601-90003
• 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