MAUDE Adverse Event Report: ALPHATEC SPINE, INC. INVICTUS; TAP, BONE

Model Number	17109-055
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/12/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that while tapping a hole in the patient's bone, the tap sheared off.The sheared tip remains in the patient.
Additional Manufacturer Narrative
The device did not return for investigation.The lot number was not provided; therefore, a review of the device history records cannot be performed.Radiograph images were provided which confirm the complaint.Based on the information, the root cause is unknown.Multiple attempts have been made to obtain information.If additional information and/or the device are provided, a supplemental report will be filled accordingly.

• Brand Name: INVICTUS
• Common Device Name: TAP, BONE
• Manufacturer (Section D): ALPHATEC SPINE, INC.; 1950 camino vida roble; carlsbad CA 92008
• Manufacturer (Section G): ALPHATEC SPINE, INC.; 1950 camino vida roble; carlsbad CA 92008
• Manufacturer Contact: wesley channell ; 1950 camino vida roble; carlsbad, CA 92008 ; 9014283693
• MDR Report Key: 19724520
• Report Number: 2027467-2024-00078
• Device Sequence Number: 8206684
• Product Code: HWX
• UDI-Device Identifier: 00190376192079
• UDI-Public: (01)00190376192079
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/11/2024

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 Model Number: 17109-055
• Device Catalogue Number: 17109-055
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2024
• Initial Report FDA Received Date: 07/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 47 YR
• Patient Sex: Female