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

Model Number 2112-90006

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/01/2022

Event Type  malfunction  

Manufacturer Narrative

Lot harn (1): device not returned.

Event Description

This record is a consolidation of q3 2022 records summarized as a part of the fda voluntary malfunction summary reporting program.This report captures one instance of intraoperative mesa reduction jack tip fracture.The associated procedure was completed successfully with no surgical delay and no adverse consequence to the patient.

Manufacturer Narrative

Lot harn (1): manufacture date 25 june 2018, device not returned.

Event Description

This record is a consolidation of q3 2022 records summarized as a part of the fda voluntary malfunction summary reporting program.This report captures one instance of intraoperative mesa reduction jack tip fracture.The associated procedure was completed successfully with no surgical delay and no adverse consequence to the patient.

• Brand Name: REDUCTION JACK; CRICKET 2
• Type of Device: 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: 15705078
• MDR Text Key: 307099318
• Report Number: 3004774118-2022-00381
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 10888857033634
• UDI-Public: 10888857033634
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2112-90006
• Device Catalogue Number: 6201-90084
• Device Lot Number: HARN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/25/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1