MAUDE Adverse Event Report: K2M, INC. REDUCTION JACK; CRICKET 2; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	6201-90084
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Lot kcrv (1): the investigation is still in process; we will communicate our findings in a follow-up report.Lot fenf (1): manufacture date 22 december 2016.The returned device was visually inspected and the fractured tip was confirmed.The device was also noted to be jammed due to threading deformation which indicates that the device was not properly seated in the implant during surgery.This may lead the user to exert excessive force which will then cause a tensile stress on the threading causing them to seize, and, ultimately, fracture of the improperly seated tip.Functional testing confirmed the device was jammed.Device history records were reviewed and no relevant manufacturing issues were identified.Complaint history was reviewed and one similar complaint for this lot number was identified.Based on the deformation of the threading, the most likely root cause of the event is improper mating and use of excessive force.
Event or Problem Description
This record is a consolidation of q1 2022 records summarized as a part of the fda voluntary malfunction summary reporting program.This report captures two instances of intraoperative mesa 2 reduction jack tip fracture.In both cases, the procedure was completed successfully with no surgical delay and no adverse consequence to the patient.
Event or Problem Description
This record is a consolidation of q1 2022 records summarized as a part of the fda voluntary malfunction summary reporting program.This report captures two instances of intraoperative mesa 2 reduction jack tip fracture.In both cases, the procedure was completed successfully with no surgical delay and no adverse consequence to the patient.
Additional Manufacturer Narrative
Lot kcrv (1): manufacture date 08 november 2019.The returned device was visually inspected and the fractured tip was confirmed and the device was also noted to be jammed due to threading deformation.Threading deformation indicates that the device was not properly seated in the implant during surgery.This may lead the user to exert excessive force which will then cause a tensile stress on the threading causing them to seize, and, ultimately, fracture of the improperly seated tip.Device history records were reviewed and no relevant manufacturing issues were identified.Complaint history was reviewed and one similar complaint for this lot number was identified.Based on the deformation of the threading, the most likely root cause of the tip fracture is improper mating and use of excessive force.Lot fenf (1): investigation conclusion provided in initial report.

• Brand Name: REDUCTION JACK; CRICKET 2
• 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: 14251953
• Report Number: 3004774118-2022-00158
• Device Sequence Number: 4338415
• Product Code: LXH
• UDI-Device Identifier: 10888857320468
• UDI-Public: 10888857320468
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 2
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/27/2022

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 Model Number: 6201-90084
• Device Catalogue Number: 6201-90084
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/01/2022
• Supplement Date Received by Manufacturer: 07/01/2022
• Initial Report FDA Received Date: 04/29/2022
• Supplement Report FDA Received Date: 07/27/2022
• 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