MAUDE Adverse Event Report: K2M, INC. TORQUE LIMITING SHAFT; SIZE 25; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	101-90101
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a denali torque limiting shaft tip deformed intra-operatively.The instrument tip twisted while attempting to remove an s1 screw, that was difficult to remove.There were no adverse consequences to the patient.The procedure was completed successfully, with a 10 minute surgical delay, by using a t-bar removal too and using a new screw.
Event or Problem Description
It was reported that a denali torque limiting shaft tip deformed intra-operatively.The instrument tip twisted while attempting to remove an s1 screw, that was difficult to remove.There were no adverse consequences to the patient.The procedure was completed successfully, with a 10 minute surgical delay, by using a t-bar removal too and using a new screw.
Additional Manufacturer Narrative
Visual, functional and dimensional 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.The denali torque limiting shaft is not indicated for screw removal.A t-bar screw remover is included in the set in order to perform this function.The subject instrument likely experienced excessive torsional load, resulting in fracture.The root cause was determined to be normal wear and user error.No further investigation for this event is possible at this time as no device was received.

• Brand Name: TORQUE LIMITING SHAFT; SIZE 25
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 10825598
• Report Number: 3004774118-2020-00303
• Device Sequence Number: 17063883
• Product Code: LXH
• UDI-Device Identifier: 10888857010048
• UDI-Public: 10888857010048
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2021

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: 101-90101
• Device Lot Number: EJBV
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/18/2020
• Supplement Date Received by Manufacturer: 02/27/2021
• Initial Report FDA Received Date: 11/11/2020
• Supplement Report FDA Received Date: 03/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1