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

Catalog Number	101-90317
Medical Device Problem Code	Fracture (1260)
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 indicating wrench broke off intra-operatively.The tip was removed and surgery was successfully completed with no delay.No adverse consequences or medical intervention were reported.
Event or Problem Description
It was reported that the tip of a denali torque indicating wrench broke off intra-operatively.The tip was removed and surgery was successfully completed with no delay.No adverse consequences or medical intervention were reported.
Additional Manufacturer Narrative
Visual inspection: the tip was confirmed to be fractured.Beach marks can be observed on the fracture surface.Discoloration and wear of the device laser markings were observed.Device and complaint history records were reviewed, and one similar complaint was identified.No relevant manufacturing issues 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.As this device was approximately nine years old at the time of event, it is likely that repeated torsional loading experienced by the device throughout its service life could have compromised the material integrity of the tip, leading to fracture.

• Brand Name: TORQUE INDICATING WRENCH; SIZE 25
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 10392378
• Report Number: 3004774118-2020-00170
• Device Sequence Number: 19557889
• Product Code: LXH
• UDI-Device Identifier: 10888857011267
• UDI-Public: 10888857011267
• 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: 101-90317
• Device Lot Number: AKLE 009
• 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