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

Catalog Number	201-90118
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a pyrenees constrained cervical tapered driver tip stripped out intra-operatively.No adverse consequences, surgical delay or medical intervention were reported.  the procedure was completed successfully.
Additional Manufacturer Narrative
Visual inspection: it was observed that the hexalobe tip was deformed.The edges of the hexalobe tip were deformed in a rotational pattern and appeared dull.Complaint history was reviewed and no similar complaints were identified.From the pyrenees surgical technique: screw insertion: insert the tifix bone screws through the plate using the size 10 tapered driver and tighten the bone screw until it begins to engage the plate.The size 10 tapered driver has a tapered, self-holding tip (stab and grab) to aid in insertion of the pyrenees screws.Correspondence with rep states that patient's bone quality was normal, and the device was used about 15 times.Excessive force was not used on the device.From the provided information, a cause cannot be determined conclusively.
Event or Problem Description
It was reported that a pyrenees constrained cervical tapered driver tip stripped out intra-operatively.No adverse consequences, surgical delay or medical intervention were reported.  the procedure was completed successfully.

• 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: 12260317
• Report Number: 3004774118-2021-00238
• Device Sequence Number: 4742978
• Product Code: LXH
• UDI-Device Identifier: 10888857030183
• UDI-Public: 10888857030183
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2021

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 Catalogue Number: 201-90118
• Device Lot Number: MPYU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/08/2021
• Supplement Date Received by Manufacturer: 10/26/2021
• Initial Report FDA Received Date: 08/02/2021
• Supplement Report FDA Received Date: 11/12/2021
• 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