MAUDE Adverse Event Report: ALPHATEC SPINE INVICTUS; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Model Number	15705-075-045;15620
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/04/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The implant is currently being evaluated.A follow-up report with the results of the investigation will be submitted upon completion.
Event or Problem Description
It was reported a tulip became disassembled during a case.This caused a delay in surgery.
Additional Manufacturer Narrative
Corrected info: b5.The initial report indicated the tulip became disengaged with screw advancement during surgery.This caused a delay in surgery.H6.Investigation findings: 115 investigation conclusion: 51, 18 h10.Observations: a review of the dhrs indicated no remarkable manufacturing or quality items that would have impacted performance relative to the complaint beyond the intended design.There are no clear indications that the design, manufacturing, or initial quality of the implants contributed to the complaint.Qty (b)(4) of pn 15610 ln to01281 were manufactured to drawing rev b and released into inventory on 08/29/2022.Qty 120 pn 15705-075-045 ln sm147519 were manufactured to drawing rev b and released into inventory on 08/10/2022.The invictus modular polyaxial reduction tulip pn 16510 and modular screw shank pn 15704-075-050 were visually and physically examined and showed no apparent signs of manufacturing defect.Both invictus modular polyaxial reduction tulips pn 15610 were returned in a deployed state, neither reduction tulips display any visible damage or material deformation.The collets have not been deformed and do not demonstrate any markings inconsistent with a typical deployment.Based on the markings on the single returned invictus modular mis shank pn 15705-075-045 and the intact reduction tulip, it appears that the spherical head was properly captured in the tulip prior to deployment.The tulips popped off / disengaged from the shank prior to rod reduction during screw advancement; subsequently the reduction of the rod deployed the tulips and there are markings on the collet consistent with rod contact and lockdown.The other reduction tulip was received not intact, the bushing had been pushed out of the tulip assembly distally.This occurs when the tulip is being deployed without the spherical head of the shank captured and the inserter instrument plunger or some other material is able to push the bushing distally through the collet prior to deployment.Once the tulip is deployed the bushing cannot be pushed out of the assembly distally as it is retained.Based on previous complaint investigations, this could be a result of the inserter plunger pushing the bushing and spherical head of the shank distally out of the tulip upon loading, the shanks were not captured following screw advancement, and when the tulip was deployed due to a rod reduction the bushing and spherical shank head were not captured within the tulip.The root cause is likely the result of the instrument not functioning properly due to debris which bound up the inner plunger shaft.The complainant did not report any issues with the inserter nor did the inserter return to alphatec for evaluation.The disassembled individual components were reviewed and did not reflect any shearing or deforming outside of the loading conditions described above.Failure mode and root cause: the modular tulips failed to capture and retain the screw shank head during screw advancement is unknown but may be a result of the inserter instrument malfunctioning or improper adherence to the surgical technique.The implant failed to properly capture and retain a modular shank when deployed due to improper function of a dirty instrument in which the implant was not fully loaded/threaded but the instrument could be "deployed".The root cause is likely the result of the instrument not functioning properly due to debris which bound up the inner plunger shaft.While it is likely the failure was a result of improper cleaning of the inserter.Review of the complaints database indicates there have been no reports received against the inserter from the instrument set used during this case.In addition, our erp system shows the inserters remain in the set which is still in the field.It is likely they have been properly cleaned since this case.Labeling review: ins-111 rev y "possible adverse effects: the following complications and adverse reactions have been shown to occur with the use of similar spinal instrumentation.These effects and any other known by the surgeon must be discussed with the patient preoperatively.1.Initial or delayed loosening, disassembly, bending, dislocation, and/or breakage of device components" "instrument preparation: · cleaning, inspection, lubrication, and sterilization must be performed by hospital personnel trained in the general procedures involving contaminant removal.· instruments must be cleaned prior to lubrication and sterilization.· all instrument hinged, rotating, and articulating parts must be lubricated prior to sterilization with a water soluble and sterilizable lubricant intended for surgical instruments (hinge-free® for example).· certain instruments may be disassembled prior to cleaning.Tulip inserter: to disassemble the tulip inserter for cleaning, push distal plunger up proximally until it bottoms out within the device.While holding the position of the plunger, squeeze the handles together until the button above the thumbwheel pops out and gold sides of the button are visible.Cleaning instructions for all instruments: · instruments must be cleaned prior to sterilization.Cleaning, maintenance and mechanical inspection must be performed by hospital personnel trained in the general procedures involving contaminant removal.· disconnect all handles/knobs prior to cleaning.· complex instruments, such as those with, cannulas, hinges, retractable features, mated surfaces, and textured surface finishes, require special attention during cleaning.Brush tight tolerance areas with an appropriately sized brush and flush using a water jet or syringe where debris could become trapped.Visually inspect each instrument for deterioration such as corrosion and worn components; ensure that the laser markings are legible and verify that all actuating parts move freely.Visual inspection must be performed at each cleaning to determine if an instrument is acceptable for use.If an instrument is not acceptable for use, return to the manufacturer.".

• Brand Name: INVICTUS
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• Manufacturer (Section D): ALPHATEC SPINE; 1950 camino vide roble; carlsbad CA 92008
• Manufacturer Contact: wesley channell ; 1950 camino vida roble; carlsbad, CA 92008 ; 9014283693
• MDR Report Key: 15724658
• Report Number: 2027467-2022-00080
• Device Sequence Number: 7541879
• Product Code: KWP
• UDI-Device Identifier: 00190376236988
• UDI-Public: (01)00190376236988(10)SM147519;(01)00190376236124(10)TO01281
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K192938
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2022

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
• Device Model Number: 15705-075-045;15620
• Device Catalogue Number: 15705-075-045;15620
• Device Lot Number: SM147519;TO01281
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/05/2022
• Supplement Date Received by Manufacturer: 10/05/2022
• Initial Report FDA Received Date: 11/04/2022
• Supplement Report FDA Received Date: 12/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/10/2022
• 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
• Patient Age: 66 YR
• Patient Sex: Female