MAUDE Adverse Event Report: K2M, INC. DEFORMITY ROD REDUCER BASE CAMP; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	2901-90110
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/05/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the everest deformity rod reducer base camp would not grab the screw head intra-operatively and after the case it was noticed that the portions that grab the screw head were splayed.The surgery was completed successfully.No adverse consequences, surgical delay or medical intervention were reported.
Event or Problem Description
It was initially reported that the everest deformity rod reducer base camp would not grab the screw head intra-operatively.The surgery was completed successfully.No adverse consequences, surgical delay or medical intervention were reported.Additional review of this event indicates this incident to be non-reportable.
Additional Manufacturer Narrative
It was reported that the everest deformity rod reducer base camp would not grab the screw head intra-operatively and after the case it was noticed that the portions that grab the screw head were splayed.Additional review of the events indicates this incident to be non-reportable.The event caused no serious deterioration in the state of health of a patient or user.Review of product and complaint history indicates that no prior similar incidents have led to a serious deterioration in the past, nor is a recurrence of this incident likely to lead to a serious deterioration in the future.

• Brand Name: DEFORMITY ROD REDUCER BASE CAMP
• 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: 15138361
• Report Number: 3004774118-2022-00311
• Device Sequence Number: 7267431
• Product Code: LXH
• UDI-Device Identifier: 10888857040663
• UDI-Public: 10888857040663
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/02/2022

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: 2901-90110
• Device Catalogue Number: 2901-90110
• Device Lot Number: DGGRA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/05/2022
• Supplement Date Received by Manufacturer: 08/05/2022
• Initial Report FDA Received Date: 08/01/2022
• Supplement Report FDA Received Date: 09/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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