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

Catalog Number	201-90133
Medical Device Problem Code	Material Deformation (2976)
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 second of two pyrenees sized 10 non-tapered torque drivers.
Additional Manufacturer Narrative
Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.Visual inspection was performed and confirmed tip deformation.Rotational deformation is observed on the entire hexalobe.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).It was also reported that the surgeon uses the torque limiting handle but will torque until it almost breaks and then back off; they continue to do this multiple times.Complaint history was reviewed and similar complaints for this lot number were identified.Device stg was reviewed: after all the smartlock bone screws have been secured, utilize the torque limiting handle in conjunction with the torque limiting hexalobe shaft for final tightening of the bone screws.The torque limiting screwdriver is designed to provide a locking torque of 20 in-lbs (2.3 nm) and help ensure the smartlock technology is fully engaged and not over tightened.The anti-torque instrument is available for both pyrenees constrained and translational.This instrument docks onto the plate and is used as an anti-torque device when final tightening.The most likely cause of the reported event was determined to be multifactorial.The main contributing factor was determined to be normal wear due to be the high volume of normal usage of this instrument.An additional contributing factor is most likely the technique of multiple attempts of torqueing the screws during final tightening.Although this technique is not contraindicated, it increases the number of times torsional stress is applied to the driver and may cause device to fatigue more rapidly than normal.
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 second of two pyrenees sized 10 non-tapered torque drivers.

• 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: 13446896
• Report Number: 3004774118-2022-00044
• Device Sequence Number: 14818323
• Product Code: LXH
• UDI-Device Identifier: 10888857030244
• UDI-Public: 10888857030244
• 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: 201-90133
• Device Lot Number: MNGJ
• 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
• Date Device Manufactured: 02/08/2021
• 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