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

Catalog Number	6201-90084
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
Event or Problem Description
This report summarizes one malfunction event where the tip of an mesa 2 reduction jack cricket broke intra-operatively.The procedure was successfully completed with a two minute surgical delay.No adverse consequences or medical intervention were reported.
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 was not returned.Device and complaint history records were reviewed for this lot, and no relevant manufacturing issues or similar complaints were identified.It was reported that a difficult angle was not evident and it was regular rod reduction being performed.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 may also have contributed to the event.

• 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
• MDR Report Key: 12714606
• Report Number: 3004774118-2021-00328
• Device Sequence Number: 5760382
• 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: 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): 10/28/2021

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: 6201-90084
• Device Lot Number: HGTB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/01/2021
• Initial Report FDA Received Date: 10/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1