MAUDE Adverse Event Report: CHOICESPINE, LLC SURGERY. DR. KNETSCHE AND HIS DISTRIBUTOR RETURNED THE SCREWS AND ASSOCIATED HAR; LANCER,THUNDERBOLT,SET SCREW,NEW THREAD

Model Number	MT20-0002
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	11/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Images were obtained for all pedicle screws, set screws, and rods associated with the complaint, which found uniform depressions of the rod on the set screw and pedicle screw core for the t12 - l4 constructs.The edges of the tulip slot where the rod would rest was also photographed and little to no deformation or damage was found on the t12 - l4 constructs.Conversely, the l5 and s1 tulip slots had significant deformation present on one side of the tulip and the set screws and/or tulip cores had deformation in multiple locations, which would indicate that the rod was not fully reduced in situ.Investigation of the torque required to back out of unlock the new set screws (mt20-0002) versus the old set screws (mt20-0001) was performed with off the shelf production implants (mt11-654-120, mt10-6550, mt20-0001, mt20-0002, mt20-p090, and mt20-p095) at a locking torque of 70 in/lbs.Results of the testing indicated that the unlocking torque for the new set screws was greater than that of the old set screws (43.20 in/lbs.& 33.67 in/lbs., respectively).The unlocking torque of the new set screw is lower than that of the old set screw if there is a gap present between the rod and the tulip (14.90 in/lbs.& 17.90 in/lbs., respectively); however, only n=1 was performed and the difference between unlocking torque is not significant (3 in/lbs.).The part numbers and lot numbers were evaluated for each device returned, which yielded no correlation between manufacturing dates or manufactures.A definite root cause can't be determined at this time; however, due to the uneven scoring or wear patterns noted on the l5 and s1 constructs, in addition to review of the immediate post-operative images, the rod length may have been too short for the construct.
Event or Problem Description
Dr.(b)(6) performed a thunderbolt revision on a patient on (b)(6)2023.He removed the original pedicle screws as there was believed to be set screw disengagement on some of the levels.This can be seen in the images below prior to the revision surgery.Dr.(b)(6) and his distributor returned the screws and associated hardware to choicespine for investigation and analysis.The hardware was provided to the engineering team for investigation in conjunction with quality department.The original surgery information was: original surgery date: on (b)(6) 2023 t12-l1, l1-2, l2-3, l3-4, l4-5 dlif, l5-s1 alif, t12-s1 psf the revision was completed on (b)(6) 2023 t12-s1 psf revision, r/t set screws popped out.Each level screw and set screw is labeled in their own cup.Rods also labeled.

• Brand Name: SURGERY. DR. KNETSCHE AND HIS DISTRIBUTOR RETURNED THE SCREWS AND ASSOCIATED HAR
• Common Device Name: LANCER,THUNDERBOLT,SET SCREW,NEW THREAD
• Manufacturer (Section D): CHOICESPINE, LLC; 400 erin drive; knoxville TN 37919
• Manufacturer (Section G): CHOICESPINE, LLC; 400 erin drive; knoxville TN 37919
• Manufacturer Contact: tracy huling ; 400 erin drive; knoxville, TN 37919 ; 8652433967
• MDR Report Key: 18334375
• Report Number: 3005819474-2023-00010
• Device Sequence Number: 12865756
• Product Code: KWP
• UDI-Device Identifier: 00840996187404
• UDI-Public: 00840996187404
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K171456
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 11/28/2023

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?: No
• Operator of Device: Health Professional
• Device Model Number: MT20-0002
• Device Lot Number: 9942-10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/28/2023
• Initial Report FDA Received Date: 12/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male