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	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 two (2) devices have been returned for analysis: lot kdjr: received 10/jun/2021, lot mcvf: received 10/jun/2021.A supplemental vmsr will be submitted upon completion of the investigations.
Event or Problem Description
This report summarizes two malfunction events where the tips of yukon oct polyaxial screw inserters got "stuck in the screw head" intra-operatively.The procedure was successfully completed with another inserter and no delay.No adverse consequences or medical intervention were reported.
Event or Problem Description
This report summarizes two malfunction events where the tips of yukon oct polyaxial screw inserters got "stuck in the screw head" intra-operatively.The procedure was successfully completed with another inserter 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: no deformities or abnormalities were observed upon receipt.Functional inspection: the inserters were able to engage and disengage as intended with a sample yukon screw.A review of complaint history associated with the subject catalog number was performed, and no adverse trends were observed.As the reported failure could not be replicated, we were unable to determine the root cause conclusively.It is possible that patient anatomy played a factor.According to the rep, the screw was inserted at a difficult angle.The saddle of the screw must be completely aligned with the shaft to be able to disengage the screw inserter.Shallow trajectories can have challenges as patient anatomy can shift the saddle, preventing proper alignment for disengagement.

• Brand Name: SCREW INSERTER
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 12247658
• Report Number: 3004774118-2021-00230
• Device Sequence Number: 4440676
• 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): 10/27/2021

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: 7601-90003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2021
• 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: 10/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1