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	03/31/2021
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 investigation.
Event or Problem Description
This report summarizes one malfunction event where the tip of a yukon oct polyaxial screw inserter jammed during device inspection pre-operatively.Surgery was successfully completed with an unknown 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: the inserter shows few signs of cosmetic wear on the tip.Functional inspection: both hexalobe features on the inserter and the screw were aligned, and were able engage without any restrictions.The reported failure was only seen sporadically during immediate disengagement and when torque was applied to the system.Hence, this issue could not be consistently replicated.As the instrument was found with jamming issues, it is unclear how and when the incident occurred and what surgical steps were taken during previous surgeries, with the screw inserter.Inserting the screw with more force than normal, on a bone, can compound torsional forces at the screw/inserter interface, compromising the insertion feature of the screw head.As mentioned in the product ifu, to fully seat the inserter into the screw-head, the inserter has to be completely aligned with the screw.Ensuring that the screw is securely engaged in the inserter tip can assist in distributing forces evenly throughout the screw/inserter interface, reduce torque overloading, and reduce failures as reported.
Event or Problem Description
This report summarizes one malfunction event where the tip of a yukon oct polyaxial screw inserter jammed during device inspection pre-operatively.Surgery was successfully completed with an unknown 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
• MDR Report Key: 11745385
• Report Number: 3004774118-2021-00125
• Device Sequence Number: 4319014
• 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: 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): 07/26/2021

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
• Device Lot Number: HVWE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2021
• Initial Date Received by Manufacturer: 03/31/2021
• Supplement Date Received by Manufacturer: 07/01/2021
• Initial Report FDA Received Date: 04/29/2021
• Supplement Report FDA Received Date: 07/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1