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	04/12/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tips of 4 denali torque limiting shaft fractured intra-operatively.No adverse consequences, surgical delay or medical intervention were reported.The procedure was completed successfully.This report captures the first of the four torque limiting shafts.
Event or Problem Description
It was reported that the tips of 4 denali torque limiting shaft fractured intra-operatively.No adverse consequences, surgical delay or medical intervention were reported.The procedure was completed successfully.This report captures the first of the four torque limiting shafts.
Additional Manufacturer Narrative
Visual inspection: tip of of the device was confirmed to be deformed.Device history records were reviewed for this lot, and no relevant manufacturing issues were identified.Complaint history records were reviewed for this lot, similar complaints were identified.Upon correspondence with rep, it was communicated that the device was used during removal.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.

• 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: 11806396
• Report Number: 3004774118-2021-00138
• Device Sequence Number: 19744547
• Product Code: LXH
• UDI-Device Identifier: 10888857010529
• UDI-Public: 10888857010529
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 09/07/2021

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: ELKP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2021
• Initial Date Received by Manufacturer: 04/12/2021
• Supplement Date Received by Manufacturer: 08/10/2021
• Initial Report FDA Received Date: 05/11/2021
• Supplement Report FDA Received Date: 09/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1