MAUDE Adverse Event Report: K2M, INC. NON-TAPERED TORQUE DRIVER; SIZE 10; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	201-90133
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tip of a pyrenees non-tapered torque driver broke off intra-operatively.The fractured piece was removed from the surgical site.There were no adverse consequences to the patient.The procedure was completed successfully without surgical delay by using an alternatively available device.
Event or Problem Description
It was reported that the tip of a pyrenees non-tapered torque driver broke off intra-operatively.The fractured piece was removed from the surgical site.There were no adverse consequences to the patient.The procedure was completed successfully without surgical delay by using an alternatively available device.
Additional Manufacturer Narrative
The device has been received and fields d9/h3 have been updated.
Additional Manufacturer Narrative
The driver was observed to be fractured at the tip, the fracture indicated an excessive torsional force.Device history records were reviewed for this lot, no relevant manufacturing issues were identified.Complaint history records were reviewed for this catalog number, no adverse trends identified.Three attempts were made to obtain additional information but no correspondence was received.Based on the fracture the failure mode indicates excessive torsional force applied on the driver.Another possible cause of this failure mode is wear and tear from frequent use as the device was manufactured in 2015 making it about seven years old.Due to the age of the device, the most likely cause of the event was determined to be due to normal wear.Excessive torque most likely contributed to the event as well.
Event or Problem Description
It was reported that the tip of a pyrenees non-tapered torque driver broke off intra-operatively.The fractured piece was removed from the surgical site.There were no adverse consequences to the patient.The procedure was completed successfully without surgical delay by using an alternatively available device.

• Brand Name: NON-TAPERED TORQUE DRIVER; SIZE 10
• 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: 13933040
• Report Number: 3004774118-2022-00114
• Device Sequence Number: 14635346
• Product Code: LXH
• UDI-Device Identifier: 10888857030244
• UDI-Public: 10888857030244
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/08/2022

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: 201-90133
• Device Catalogue Number: 201-90133
• Device Lot Number: DXHD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/15/2022
• Supplement Date Received by Manufacturer: 04/25/2022; 06/10/2022
• Initial Report FDA Received Date: 03/28/2022
• Supplement Report FDA Received Date: 05/17/2022; 07/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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