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 Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tip of a denali torque limiting shaft stripped during final torquing intra-operatively.Surgery was successfully completed with second shaft and no delay.No adverse consequences or medical intervention were reported.
Additional Manufacturer Narrative
Visual inspection: tip of of the device was confirmed to be deformed.The tip was deformed in a clockwise, rotational pattern.Device and complaint history records were reviewed, and no relevant manufacturing issues or similar complaints were identified.Per the surgical technique: final tightening of denali implants is achieved utilizing either the anti-torque alignment tube or praying mantis attached to the anti-torque handle.Ensure the sliding mechanism of the anti-torque handle is facing up to lock onto the instrument (figure f).Slide the handle over the small diameter of the tube and then push down onto the hex portion of the instrument.To disengage the handle, pull back on the sliding mechanism and lift up.Insert the torque wrench into the top opening of the assembled praying mantis and anti-torque handle before positioning it on the screw.Introduce the torque wrench tip into the set screw, and then slide the assembled handle down to engage the screw.Final torque tightening may now be completed.The torque indicating wrench or assembled torque limiting wrench and torque limiting shaft both achieve 90 in-lbs of torque for final tightening.The torque limiting wrench will "pop" once the necessary torque is achieved.The proper torque level is achieved with the torque indicating wrench when the line and arrow meet.Do not exceed the recommended torque or damage to the instrument or implant may result.The observed deformation pattern indicates that the damage occurred during tightening.It is likely that the torque limiting shaft was over-torqued during final tightening, resulting in tip deformation.The denali surgical technique notes that the torque limiting shaft will experience damage if torqued beyond the recommended 90 in-lbs; the torque limiting wrench will "pop" once the necessary torque is achieved.
Event or Problem Description
It was reported that the tip of a denali torque limiting shaft stripped during final torquing intra-operatively.Surgery was successfully completed with second shaft and no delay.No adverse consequences or medical intervention were reported.

• 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: 10392506
• Report Number: 3004774118-2020-00169
• Device Sequence Number: 16868522
• Product Code: LXH
• UDI-Device Identifier: 10888857010048
• UDI-Public: 10888857010048
• Combination Product (Y/N): N
• Initial Reporter Country: ZA
• 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): 10/27/2020

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: GNML
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2020
• Initial Date Received by Manufacturer: 07/15/2020
• Supplement Date Received by Manufacturer: 09/29/2020
• Initial Report FDA Received Date: 08/11/2020
• Supplement Report FDA Received Date: 10/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1