MAUDE Adverse Event Report: K2M, INC. MESA RAIL / ROD PULLER; MESA RAIL; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number	801-90143
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	12/18/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Status and location of the device is currently unknown.
Event or Problem Description
It was reported that a mesa rod puller tip deformed intra-operatively while attempting to unlock a 4th screw after successfully unlocking 3 screws.
Additional Manufacturer Narrative
Correction was made to section b1 and h1 to reflect serious injury.Visual inspection: device was inspected and found to have a deformed distal tip.Instrument appears to have been misused and was likely bent while connected to the assembly which caused damage to the device.One of the prongs was bent outward which suggests that the device was exposed to a bending force which it is not indicated for.Device and complaint history records were reviewed and no relevant manufacturing issues or simiar complaints were identified as all units met stryker specifications.Mesa rail surgical technique was reviewed and the following relevant information was identified: unlocking & removal: should the surgeon decide to unlock the mesa screw from partial or full lock, the rail unlocker may be used.Fully open the instrument and engage the docking feet into the detents of the medial side of the screw housing.Gently move the instrument down laterally until the distal portion of the instrument has properly engaged both the medial and lateral side of the screw housing.Fully squeeze the lever of the rail unlocker.Once the screw is in the unlocked position, the mesa rail may be extracted from the implant housing using the rail puller.Apply the distal end of the rail puller over the screw housing and rotate it in a clockwise direction until it securely engages the mesa rail.Grab the handle and thread down in a controlled fashion in order to release the mesa rail from the screw head.It appears that the most likely root cause for the issue was instrument misuse, as the device experienced loading that it was not indicated for, and was ultimately damaged by it.
Event or Problem Description
It was reported that a mesa rod puller tip deformed intra-operatively while attempting to unlock a 4th screw after successfully unlocking 3.This contributed to a 2.5 hour surgical delay.

• Brand Name: MESA RAIL / ROD PULLER; MESA RAIL
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 9539494
• Report Number: 3004774118-2020-00001
• Device Sequence Number: 2407789
• Product Code: LXH
• UDI-Device Identifier: 10888857143654
• UDI-Public: 10888857143654
• 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): 05/22/2020

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: 801-90143
• Device Lot Number: EAXKA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2020
• Initial Date Received by Manufacturer: 12/18/2019
• Supplement Date Received by Manufacturer: 04/28/2020
• Initial Report FDA Received Date: 01/02/2020
• Supplement Report FDA Received Date: 05/22/2020
• 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