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	12/08/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during final tightening, two denali spinal system torque limiting shafts twisted intra-operatively.The procedure was completed successfully with a 5 min surgical delay.No adverse consequences or medical intervention were reported.This report represents the first torque limiting shafts.
Additional Manufacturer Narrative
The returned device was inspected, and the distal tip was observed to be slightly deformed.Device and complaint history records were reviewed for this lot, and no relevant manufacturing issues or similar complaints were identified.The observed deformation pattern indicates that the damage occurred during tightening.Upon correspondence with rep, it was communicated that the tip of driver twisted before the torque limiting handle clicked.As the device was manufactured in 2017, it is possible that repeated use of the instrument during its service life weakened the material integrity at the tip, contributing to tip deformation.
Event or Problem Description
It was reported that during final tightening, two denali spinal system torque limiting shafts twisted intra-operatively.The procedure was completed successfully with a 5 min surgical delay.No adverse consequences or medical intervention were reported.This report represents the first torque limiting shafts.

• 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: 11108068
• Report Number: 3004774118-2021-00001
• Device Sequence Number: 19814120
• Product Code: LXH
• UDI-Device Identifier: 10888857010048
• UDI-Public: 10888857010048
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2021

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: GCVY
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2020
• Initial Date Received by Manufacturer: 12/08/2020
• Supplement Date Received by Manufacturer: 03/29/2021
• Initial Report FDA Received Date: 01/04/2021
• Supplement Report FDA Received Date: 04/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1