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

Catalog Number	101-90101
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a denali torque limiting shaft broke off during set screw removal intra-operatively.No adverse consequences or medical intervention were reported. the procedure was successfully completed with another device.
Event or Problem Description
It was reported that a denali torque limiting shaft broke off during set screw removal intra-operatively.No adverse consequences or medical intervention were reported. the procedure was successfully completed with another device.
Additional Manufacturer Narrative
Visual inspection: tip of the device was confirmed to be fractured.Device and complaint history records were reviewed for this lot, and no relevant manufacturing issues or similar complaints were identified.The denali surgical technique advises against exceeding the recommended torque limit, as it can cause damage to the instrument and implant.The denali torque limiting shaft is meant to be used for final tightening of set screws, not removal- which likely exceeded the sustainable torque limit.A set screw removal wrench is included in the set to aid in set screw removal.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 as well, contributing to the observed fracture.

• 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: 11995769
• Report Number: 3004774118-2021-00178
• Device Sequence Number: 860874
• Product Code: LXH
• UDI-Device Identifier: 10888857010048
• UDI-Public: 10888857010048
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/13/2021

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: 06/10/2021
• Initial Date Received by Manufacturer: 05/17/2021
• Supplement Date Received by Manufacturer: 09/15/2021
• Initial Report FDA Received Date: 06/14/2021
• Supplement Report FDA Received Date: 10/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1