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

Catalog Number	201-90118
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tip of the pyrenees tapered driver broke during screw insertion intra-operatively.The procedure was completed successfully with a two minute surgical delay.No adverse consequences nor medical intervention were reported.
Additional Manufacturer Narrative
Visual inspection was performed and confirmed tip fracture.Rotational deformation is observed immediately proximal to fracture.Complaint history records were reviewed for this lot, no similar complaints were identified.It was reported that the device was not used at a difficult angle, but that excessive force had to be used due to patients hard bone.Patient has osteoporotic bone.The most likely cause of the reported event was determined to be due to the patient's hard bone, which required excessive torque to insert screws.
Event or Problem Description
It was reported that the tip of the pyrenees tapered driver broke during screw insertion intra-operatively.The procedure was completed successfully with a two minute surgical delay.No adverse consequences nor medical intervention were reported.

• Brand Name: TAPERED 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: 12844943
• Report Number: 3004774118-2021-00362
• Device Sequence Number: 17201648
• Product Code: LXH
• UDI-Device Identifier: 10888857030183
• UDI-Public: 10888857030183
• 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
• Report Date (Section B): 03/10/2022

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 Catalogue Number: 201-90118
• Device Lot Number: NAKB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/11/2021
• Supplement Date Received by Manufacturer: 02/11/2022
• Initial Report FDA Received Date: 11/19/2021
• Supplement Report FDA Received Date: 03/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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