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

Catalog Number	201-90118
Medical Device Problem Codes	Material Deformation (2976); Naturally Worn (2988)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A company representative reported that a pyrenees size 10 tapered driver would not hold the screws and two pyrenees sized 10 non-tapered torque drivers had deformed threading.The procedure was completed successfully with no surgical delay and no adverse consequence to the patient.This report captures the pyrenees size 10 tapered driver.
Event or Problem Description
A company representative reported that a pyrenees size 10 tapered driver would not hold the screws and two pyrenees sized 10 non-tapered torque drivers had deformed threading.The procedure was completed successfully with no surgical delay and no adverse consequence to the patient.This report captures the pyrenees size 10 tapered driver.
Additional Manufacturer Narrative
Visual inspection confirms material wear is observed on the hexalobe of driver.Functional inspection confirms screws do not sit flush on driver tip and can disengage.The field representative reported that the surgeon has a high volume of cases and it is calculated that these devices see 1250 to 3750 uses per year (2 or 3 level fusion cases, 2 or 3 cases/day, 2 or 3 days/week).Complaint history was reviewed and similar complaints for this lot number were identified.The most likely cause of the reported event was determined to be due to high volume of normal usage.A high frequency of normal use can cause material to wear more quickly than normally.

• 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: 13446897
• Report Number: 3004774118-2022-00042
• Device Sequence Number: 5437064
• 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): 05/06/2022

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: NBMW
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/05/2022
• Supplement Date Received by Manufacturer: 04/07/2022
• Initial Report FDA Received Date: 02/03/2022
• Supplement Report FDA Received Date: 05/07/2022
• 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