MAUDE Adverse Event Report: K2M, INC. TORQUE LIMITING HANDLE; SIZE 20 IN-LBS (2.3 N-M); ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	201-90140
Medical Device Problem Code	Calibration Problem (2890)
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 two pyrenees non-tapered torque drivers broke, and the pyrenees torque limiting handle was suspected to be out of calibration intra-operatively.The procedure was completed successfully without surgical delay.No adverse consequences occurred.This record captures the pyrenees torque limiting handle.
Event or Problem Description
It was reported that two pyrenees non-tapered torque drivers broke, and the pyrenees torque limiting handle was suspected to be out of calibration intra-operatively.The procedure was completed successfully without surgical delay.No adverse consequences occurred.This record captures the pyrenees torque limiting handle.
Additional Manufacturer Narrative
A visual inspection was performed and no issues were found.A functional inspection was performed which confirmed that the torque limiting driver was off calibration.Device history records were reviewed for the corresponding lot and no relevant issues were identified.Device was manufactured in mar-2011 and was 10 years old at the time of the reported event.Complaint history record review was performed for this lot, and no similar complaints were identified.Initial report states that two drivers fractured and that the associated torque limiting driver may be off calibration.A functional inspection was performed on the torque limiting handle and found the handles torque limit to be out of spec.Torque limit was found to range from 38.219 to 42.921 in-lbs, with an average of 39.773 in-lbs, n=4.Acceptance criteria is 20.0 +/- 2.0 in-lbs.The most recent torque inspection was performed in aug-2018, 3 years prior to event.The most likely cause of the reported event was determined to be due to the device age and time since previous calibration inspection (over 3 years).

• Brand Name: TORQUE LIMITING HANDLE; SIZE 20 IN-LBS (2.3 N-M)
• 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: 12962575
• Report Number: 3004774118-2021-00386
• Device Sequence Number: 5424115
• Product Code: LXH
• UDI-Device Identifier: 10888857030299
• UDI-Public: 10888857030299
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 03/15/2022

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: 201-90140
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/11/2021
• Supplement Date Received by Manufacturer: 02/18/2022
• Initial Report FDA Received Date: 12/08/2021
• Supplement Report FDA Received Date: 03/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/03/2011
• 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