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

Catalog Number	5101-90219
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Injury (2348)
Date of Event	08/14/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during intra-operative rod reduction a screw became stuck in an everest xt support tower reducer and the reducer knob jammed causing the pedicle at l5 to break.The surgeon was then unable to place a screw at the right l5 leading to only unilateral posterior fixation being achieved.This subsequently led to an approximate 2-3 hour surgical delay.This record represents the xt support tower reducer.
Event or Problem Description
It was reported that during intra-operative rod reduction a screw became stuck in an everest xt support tower reducer and the reducer knob jammed causing the pedicle at l5 to break.The surgeon was then unable to place a screw at the right l5 leading to only unilateral posterior fixation being achieved.This subsequently led to an approximate 2-3 hour surgical delay.This record represents the xt support tower reducer.
Additional Manufacturer Narrative
H6, clinical signs grid has been updated from 'no clinical signs, symptoms, or conditions' to 'bone fracture(s).The device was inspected, and it was observed that the instrument has consistent wear marks throughout the body.Functional inspection revealed that the proximal knob assembly and snap assembly were jammed, preventing proper function of the instrument.Higher forces were applied to detach the xt support tower from the xt screw.Device and complaint history records were reviewed fort his lot, no relevant manufacturing issues or similar complaints were identified.The everest mi xt surgical technique was reviewed and the following relevant information was identified: screw insertion: to achieve one-step insertion of the everest mi xt screw and xtower, first assemble the xtower to the xt screw.Slide the xtower over the xt screw, and turn the black knob of the xtower in a clockwise direction until an audible click is emitted and the laser marked arrows are aligned.To lock the xtower onto the xt screw, turn the gold knob in a clockwise direction until fully tightened.Pull the xtower upwards to ensure the construct is locked.When using an everest mi xtower locking screw inserter, grasp the xtower by the shaft, and apply a downward force to engage the screw into the hexalobe fitting of the screwdriver shaft.Thread the gold thumb knob of the inserter in a clockwise direction until the implant is securely attached to the inserter.Pull up on the thumb knob to engage the locking feature of the inserter.To disengage the screw inserter, pull down on the thumb knob to disengage the locking feature.Gently turn the thumb knob in a counter-clockwise direction, and remove it from the surgical field.Ratcheting handles are available in both palm and t-handle styles.Tighten or loosen positions are selected by adjusting the pull down knob into forward, neutral, or reverse.Note: everest mi xt screws can be inserted prior to assembling with the xtower.Proper assembly requires the two arrows to be aligned on the xt support tower.The instrument was seen to be assembled incorrectly, resulting in the jamming of the xt tower reducer and preventing proper function of the instrument construct.The cause of this failure was determined to be user error.

• Brand Name: XT SUPPORT TOWER REDUCER
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 10509838
• Report Number: 3004774118-2020-00205
• Device Sequence Number: 3546163
• Product Code: LXH
• UDI-Device Identifier: 10888857325975
• UDI-Public: 10888857325975
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 5101-90219
• Device Lot Number: GUEY
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2020
• Initial Date Received by Manufacturer: 08/14/2020
• Supplement Date Received by Manufacturer: 10/31/2020
• Initial Report FDA Received Date: 09/09/2020
• Supplement Report FDA Received Date: 11/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other