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

Model Number	2112-90005
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A company representative reported that a capri anti-torque handle, "fell apart during surgery." the procedure was completed successfully with no surgical delay and no adverse consequence to the patient.
Additional Manufacturer Narrative
Visual inspection confirmed the handle to be disassembled.The lock key component of the anti-torque handle had fallen off of the wrench handle and disengaged from the collar.Both the spring and the press-fit 1/16" x 5/8" dowel pin, which hold the handle components together, were missing.The handle could not be reassembled without the spring and 1/16" x 5/8" dowel pin.Device history records were reviewed and no relevant manufacturing issues were identified.Complaint history was reviewed and no similar complaints for the reported catalogue number were identified.The most likely root cause is normal wear; the press-fit dowel pin was dislodged from the device after five years in the field.Wear from repeated use over time may have caused the press-fit pin to dislodge.
Event or Problem Description
A company representative reported that a capri anti-torque handle, "fell apart during surgery." the procedure was completed successfully with no surgical delay and no adverse consequence to the patient.

• Brand Name: ANTI TORQUE HANDLE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• Manufacturer (Section G): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• Manufacturer Contact: rita karan ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 14147748
• Report Number: 3004774118-2022-00155
• Device Sequence Number: 2932069
• Product Code: LXH
• UDI-Device Identifier: 10888857033627
• UDI-Public: 10888857033627
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/27/2022

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
• Device Lot Number: GBML
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/21/2022
• Supplement Date Received by Manufacturer: 06/28/2022
• Initial Report FDA Received Date: 04/19/2022
• Supplement Report FDA Received Date: 07/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/18/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown