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	07/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr is part of the fda voluntary malfunction summary reporting program.Additional information: two (2) of the four (4) devices have been returned for analysis- lot hkyu - received 4/may/2021.Lot jnxa - received 4/may/2021.A supplemental vmsr will be submitted upon completion of the investigations.
Event or Problem Description
This report summarizes four malfunction events where the tips of mesa 2 reduction jack crickets broke intra-operatively.The procedures were successfully completed with no delay or adverse consequence to the patient.
Additional Manufacturer Narrative
This mdr is part of the fda voluntary malfunction summary reporting program.Unk lots (2) - visual, functional, material and dimensional analysis could not be performed as the devices were not returned.Device and complaint history records review could not be performed as a valid lot code was not provided and could not be obtained.No further investigation for this event is possible at this time as device was not received by stryker.If devices and/or additional information become available, this investigation will be reopened lot# jnxa - manufacturing date 10/jul/2019.Lot# hkyu - manufacturing date 06/sep/2018.Visual inspection: it was confirmed that the foot of the crickets had fractured off.The fractured pieces were not returned.Device and complaint history records were reviewed for these lots, 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 may also have contributed to the event.
Event or Problem Description
This report summarizes four malfunction events where the tips of mesa 2 reduction jack crickets broke intra-operatively.The procedures were successfully completed with no delay or adverse consequence to the patient.

• 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: 12248605
• Report Number: 3004774118-2021-00232
• Device Sequence Number: 14562987
• 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: 4
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2021

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2021
• Initial Date Received by Manufacturer: 07/01/2021
• Supplement Date Received by Manufacturer: 10/01/2021
• Initial Report FDA Received Date: 07/29/2021
• Supplement Report FDA Received Date: 10/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1