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

Catalog Number	801-90066
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr is part of the fda voluntary malfunction summary reporting program.Visual inspection: it was confirmed that the foot of the cricket fractured off.The fractured piece returned.Device and complaint history records were reviewed for this lot, and no relevant manufacturing issues or similar complaints were identified.Reduction maneuvers associated with complex deformity surgeries may focus increased loads to this component, resulting in a fracture.Crickets are a valuable aid in reduction / correction maneuvers in complex deformity surgeries but are occasionally stressed beyond their structural capacity.Crickets were designed such that the significant loads encountered in complex spine surgeries are not transferred to the screw interface.Additionally, wear from the device's extended use (device was found to be 10 years old) may also have contributed to the event.Likely causes include misalignment of the feet within the screw collet causing the cricket to flex beyond its capability and/or excessive force.
Event or Problem Description
This report summarizes one malfunction event where the tip of a mesa reduction jack cricket fractured intra-operatively.All debris was removed from the patient.The procedure was successfully completed with no delay or adverse consequence.

• Brand Name: DEFORMITY REDUCTION JACK; CRICKET
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 12722645
• Report Number: 3004774118-2021-00336
• Device Sequence Number: 11832806
• Product Code: LXH
• UDI-Device Identifier: 10888857143272
• UDI-Public: 10888857143272
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/29/2021

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: 801-90066
• Device Lot Number: AJCT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/01/2021
• Initial Report FDA Received Date: 10/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1