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	10/31/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the threaded distal tip of the screw driver collar sheared off during a case.There were no patient symptoms or complications reported as result of this event.
Additional Manufacturer Narrative
The device was returned for investigation.Visual inspection confirms the tip has broken off.The failure appears to be the result of excessive force over repeated use.Review of the device history record indicates there were no issues during the manufacture of this product that would contribute to this complaint condition.

• 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: 18535912
• Report Number: 2027467-2023-00098
• Device Sequence Number: 7558224
• Product Code: HXX
• UDI-Device Identifier: 00844856069565
• UDI-Public: (01)00844856069565(10)MC4070501CR
• Combination Product (Y/N): N
• Initial Reporter State: SD
• 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): 01/18/2024

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
• Operator of Device: Health Professional
• Device Model Number: 87011
• Device Catalogue Number: 87011
• Device Lot Number: MC4070501CR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/21/2023
• Initial Report FDA Received Date: 01/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/03/2016
• 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 Sex: Unknown