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

Catalog Number	201-90133
Medical Device Problem Codes	Fracture (1260); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/13/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tips of two pyrenees constrained cervical drivers were stripped intra-operatively.There were no adverse consequences to the patient.The procedure was completed successfully without surgical delay.This report captures the first of the two drivers.
Event or Problem Description
It was reported that the tips of two pyrenees constrained cervical drivers were stripped intra-operatively.There were no adverse consequences to the patient.The procedure was completed successfully without surgical delay.This report captures the first of the two drivers.
Additional Manufacturer Narrative
Visual inspection was performed and confirmed tip fracture.Rotational deformation is observed just proximal to the fracture.The deformation is highly angulated, indicating higher than normal torque was applied to the driver during tightening.Higher than normal deformation observed in the second returned device also indicates excessive torque was applied.Device and complaint history records were reviewed for this lot number, no relevant manufacturing issues or similar complaints were identified.It was reported that the event occurred during final tightening, excessive force was not applied, and bone quality of patient was normal.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 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.

• 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: 13206338
• Report Number: 3004774118-2022-00012
• Device Sequence Number: 4651248
• 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): 04/15/2022

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: HNGJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/13/2021
• Supplement Date Received by Manufacturer: 03/18/2022
• Initial Report FDA Received Date: 01/10/2022
• Supplement Report FDA Received Date: 04/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/02/2019
• 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: Male