MAUDE Adverse Event Report: K2M, INC. ANTI TORQUE HANDLE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	2112-90005
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Hospital discarded the device.
Event or Problem Description
It was reported that the capri large expandable anti torque handle fractured intra-operatively.The fractured pieces were removed from the surgical site and the procedure was completed successfully with a 5 minute delay.No adverse consequences or medical intervention were reported.
Event or Problem Description
It was reported that the capri large expandable anti torque handle fractured intra-operatively.The fractured pieces were removed from the surgical site and the procedure was completed successfully with a 5 minute delay.No adverse consequences or medical intervention were reported.
Additional Manufacturer Narrative
Visual, dimensional, material and functional analysis could not be performed as the device was not returned.Device and complaint history records review could not be performed as a valid lot code was not provided and could not be obtained.Since no device was received by stryker, a conclusive cause for the failure mode could not be identified.Potential causes include: normal wear due to repeated use, excess force applied during the procedure.No further investigation can be performed due to insufficient information provided.If more information is received and/or devices are returned for evaluation this investigation will be reopened and updated.

• Brand Name: ANTI TORQUE HANDLE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 11112107
• Report Number: 3004774118-2021-00003
• Device Sequence Number: 17156411
• Product Code: LXH
• UDI-Device Identifier: 10888857033627
• UDI-Public: 10888857033627
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/26/2021

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 Model Number: 2112-90005
• Device Catalogue Number: 2112-90005
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/14/2020
• Supplement Date Received by Manufacturer: 04/29/2021
• Initial Report FDA Received Date: 01/04/2021
• Supplement Report FDA Received Date: 05/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1