MAUDE Adverse Event Report: ALPHATEC SPINE, INC. ARSENAL; SCREWDRIVER

Model Number	87011
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2022
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
While trying to remove previously implanted hardware (non-alphatec product), the tip of the driver sheared off.The tip was retrieved from the patient.This is report 1 of 2 for this event/patient.

• Brand Name: ARSENAL
• Common Device Name: SCREWDRIVER
• 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: 15973604
• Report Number: 2027467-2022-00095
• Device Sequence Number: 6997864
• Product Code: HXX
• UDI-Device Identifier: 00844856069565
• UDI-Public: (01)00844856069565
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 12/13/2022

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: 87011
• Device Catalogue Number: 87011
• Device Lot Number: MC4338601R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2022
• Initial Report FDA Received Date: 12/13/2022
• 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
• Patient Age: 76 YR
• Patient Sex: Male