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

Catalog Number	101-90208
Medical Device Problem Codes	Fracture (1260); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tip of the denali torque limiting shaft broke off during the final tightening of the set screws.An available spare set was used and the surgery was completed successfully.This report captures the second of two torque limiting shafts.
Additional Manufacturer Narrative
Visual, functional, and dimensional inspection could not be performed as the device was not returned.Device history records were reviewed for this lot, and no relevant manufacturing issues were identified.Complaint history records were reviewed for this lot, 4 similar complaints were identified.As the reported device was manufactured in 2016, it is possible that repeated use of the instrument during its service life weakened the material integrity at the tip, contributing to the observed deformation/fracture.However, as the device was not returned, the reported issue and cause could not be established conclusively.
Event or Problem Description
It was reported that the tip of the denali torque limiting shaft broke off during the final tightening of the set screws.An available spare set was used and the surgery was completed successfully.This report captures the second of two torque limiting shafts.

• Brand Name: TORQUE LIMITING SHAFT (SHORT); SIZE 25
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 12094561
• Report Number: 3004774118-2021-00200
• Device Sequence Number: 4000578
• Product Code: LXH
• UDI-Device Identifier: 10888857010529
• UDI-Public: 10888857010529
• 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): 10/27/2021

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: 101-90208
• Device Lot Number: FGCL
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/04/2021
• Supplement Date Received by Manufacturer: 09/30/2021
• Initial Report FDA Received Date: 06/30/2021
• 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