MAUDE Adverse Event Report: ALPHATEC SPINE, INC. INVICTUS; CROSS CONNECTOR INSERTER

Model Number	16021
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The returned device is currently being evaluated.A follow up report with results of the investigation will be submitted upon completion.
Event or Problem Description
The end of a universal cross connector inserter fractured while trying to loosen a set screw on a crosslink.
Additional Manufacturer Narrative
Correction: h8.Reuse.Device evaluation h6.Health effects: 2199.Medical device problem: 1260.Medical device component: 4742.Type of investigation: 10; 3331.Investigation findings: 4248.Investigation conclusion: 19; 61.H10.The 16021 universal cross connector inserter was received with the tip of the instrument missing.All other features of the instrument appear to be in-spec and unimpacted by the failure.Wear marks at cross sectional area where the failure occurred indicate the hexalobe sheared due to user-applied torsional force.Per communication with the rep, the hexalobe was sheared when attempting to remove an already final tightened cross connector.Shear location was at the start of the transition fillet between hexalobe and shoulder.No patient injury reported.Sheared inserter tip did not return to atec.It was likely discarded by the hospital.Root cause: during the insertion process, the surgeon over-torqued the implant greater than 40 in-lb and likely yielded the twisted hex.The inserter is indicated only to insert, and hand tighten the implant to the construct (not apply forces >40 in-lb).When the surgeon attempted to remove the final tightened implant with the 40 in-lb final torque handle, the torque required was greater than ~50in/lb and the handle was unable to apply sufficient reverse torque.He then deferred to the twisted hexalobe inserter and attempted to use it to untighten the implant, which is not an indication of use for the instrument.He then applied enough torque (~50-60 in-lb) to yield and shear the twisted hex.

• Brand Name: INVICTUS
• Common Device Name: CROSS CONNECTOR INSERTER
• 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: 12222177
• Report Number: 2027467-2021-00048
• Device Sequence Number: 3164849
• Product Code: LXH
• UDI-Device Identifier: 00190376284637
• UDI-Public: 00190376284637
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K203056
• 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): 06/23/2021

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: 16021
• Device Catalogue Number: 16021
• Device Lot Number: 8693301
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/23/2021
• Supplement Report FDA Received Date: 01/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown