MAUDE Adverse Event Report: ALPHATEC SPINE, INC INVICTUS¿ SPINAL FIXATION SYSTEM; SCREWDRIVER

Model Number	17010
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not returned.If any additional information is provided, a supplemental report will be submitted.
Event or Problem Description
During a l3-s1 revision surgery, the screwdriver broke while the surgeon was trying to implant a new screw.It was reported the revision surgery occurred because of the patient developed proximal junctional kyphosis (pjk) and bone quality.No patient injury was reported.
Additional Manufacturer Narrative
Corrected information: g3: 01/16/2020.H6: clinical code: 4582.Impact code: 2199.Medical device problem code: 1261.Component code: 4756.Type of investigation: 10; 3331.Investigation findings: 321.Investigation conclusion: 22; 23.H10: the engineering evaluation was received on 03/29/2022.Visual inspection confirmed the event the inner shaft was disassembled from the outer shaft.Review of the device history record indicates the device was manufactured in november 2019.There is a rework associated with this product.Qty 13 of this lot were returned to vendor to correct an oversized hexalobe.There were returned to alphatec on 01/16/2020.All quality inspection data suggests that this nonconformance was sufficiently corrected and would not have any influence on the investigation below.The failure mode is a result of long-term field usage, in which both (1) the pedicle screws are overtightened/fastened to the screwdriver and (2) heavy and repeated redirection loads are applied to the pedicle screws, will impart large axial loading forces on the screwdriver wing stop.The repeated loading of this component over many months/years slowly fatigues the laser beam weld until failure occurs.The root cause is likely to originate from one or two probable causes, either a failure in the manufacturing control or in normal wear as a result of proper use of the instrument.

• Brand Name: INVICTUS¿ SPINAL FIXATION SYSTEM
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): ALPHATEC SPINE, INC; 1950 camino vida roble; carlsbad CA 92008
• Manufacturer Contact: jayson alaba ; 1950 camino vida roble; carlsbad, CA 92008 ; 7604946771
• MDR Report Key: 12482360
• Report Number: 2027467-2021-00065
• Device Sequence Number: 3990747
• Product Code: HXX
• UDI-Device Identifier: 00190376192802
• UDI-Public: (01)00190376192802
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K203056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• 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): 09/15/2021

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
• Device Model Number: 17010
• Device Catalogue Number: 17010
• Device Lot Number: 8406901R
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2021
• Supplement Date Received by Manufacturer: 08/19/2021
• Initial Report FDA Received Date: 09/16/2021
• Supplement Report FDA Received Date: 04/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 43 YR
• Patient Sex: Female