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	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a pyrenees torque limiting handle was observed to be cracked during inspection.There is no procedure associated with this reported event, no patient involvement, and no adverse consequence has been reported.
Event or Problem Description
It was reported that a pyrenees torque limiting handle was observed to be cracked during inspection.There is no procedure associated with this reported event, no patient involvement, and no adverse consequence has been reported.
Additional Manufacturer Narrative
Visual inspection confirms that the handle is fractured.There is a cut in the handle.The handle still engaged and disengaged with the driver properly.Device and complaint history records were reviewed for this lot, no relevant manufacturing issues or similar complaints were identified.This device was manufactured in nov-2010 and was 11 years old at the time of reported event.The most likely cause of the reported event was determined to be due to normal wear from extended use.Material integrity can be compromised due to age.An accident or improper usage/cleaning may have contributed to the event, but could not be confirmed.

• 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: 13112578
• Report Number: 3004774118-2021-00418
• Device Sequence Number: 17264319
• Product Code: LXH
• UDI-Device Identifier: 10888857030299
• UDI-Public: 10888857030299
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2022

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
• Device Lot Number: AJJP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/16/2021
• Supplement Date Received by Manufacturer: 03/24/2022
• Initial Report FDA Received Date: 12/29/2021
• Supplement Report FDA Received Date: 04/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/22/2010
• 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