MAUDE Adverse Event Report: K2M, INC. XT SUPPORT TOWER; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	5101-90218
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/26/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an everest xt support tower was jamming intra-operatively.No adverse consequences, surgical delay or medical intervention were reported.  the procedure was completed successfully.
Additional Manufacturer Narrative
The returned everest xt support tower was visually and functionally inspected.Slight wear was noticed with scratches on the proximal knob of the device.No material deformations were observed.The gold knob was able to be rotated counter-clockwise in order to unlock the device and clockwise to lock the device.The tower was able to fully assemble and disassemble with an everest xt screw.No jamming was identified during functional testing, therefore the failure mode could not be replicated.Device and complaint history records were reviewed for this lot, and no relevant manufacturing issues or similar complaints were identified.The reported event occurred during set screw placement.The instrument was not reported to be used at a difficult angle, and no complex maneuvers or excessive forces were used on the device during the procedure.Although the jamming condition could not be replicated, the customer may have experienced issues due to device wear, as the device was about four years old at the time of event.Factors such as consistent use of the instrument throughout its lifetime may cause fatigue, leading to device wear and possible resistance.
Event or Problem Description
It was reported that an everest xt support tower was jamming intra-operatively.The procedure was completed successfully.No adverse consequences, surgical delay or medical intervention were reported.

• Brand Name: XT SUPPORT TOWER
• 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: 12333519
• Report Number: 3004774118-2021-00255
• Device Sequence Number: 16827558
• Product Code: LXH
• UDI-Device Identifier: 10888857325968
• UDI-Public: 10888857325968
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 12/09/2021

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: 5101-90218
• Device Lot Number: GBBL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/26/2021
• Supplement Date Received by Manufacturer: 11/13/2021
• Initial Report FDA Received Date: 08/17/2021
• Supplement Report FDA Received Date: 12/09/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/28/2017
• 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