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

Model Number	92939
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tip of the screwdriver broke off while removing screws.The tip was retrieved and discarded at the hospital.There were no patient symptoms or complications reported as result of this event.
Additional Manufacturer Narrative
The returned device is currently being evaluated.A follow-up report with the results of the investigation will be submitted upon completion.
Additional Manufacturer Narrative
Corrected information: h3.Yes.H6.Investigation findings: 3252.Investigation conclusions: 61.H10.The driver shaft returned to alphatec for investigation.Visual inspection confirmed the tip of the driver has broken off.The tip was not returned with the driver.The failure appears to be due to incorrect use of the device.The device is intended to be used for set screw insertion/tightening, but in this case it was used for removal of a screw.The reason for the screw removal was not provided to alphatec.Review of the device history record indicates the instrument conformed to dimensional specifications at the time of manufacturing and passed inspection requirements with no non-conformities reported.There were no issues during the manufacture of this product that would contribute to this complaint condition.Labeling review: warnings: risks identified with the use of these devices, which may require additional surgery, include device component failure, loss of fixation/stabilization, non-union, vertebral fracture, neurological injury, vascular or visceral injury.Possible adverse effects: initial or delayed loosening, disassembly, bending, dislocation and/or breakage of device components.

• Brand Name: ZODIAC
• 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: 18373291
• Report Number: 2027467-2023-00092
• Device Sequence Number: 7797519
• Product Code: HXX
• UDI-Device Identifier: 00844856044357
• UDI-Public: (01)00844856044357(10)7816601
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2023

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: 92939
• Device Catalogue Number: 92939
• Device Lot Number: 7816601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2023
• Supplement Date Received by Manufacturer: 11/21/2023
• Initial Report FDA Received Date: 12/21/2023
• Supplement Report FDA Received Date: 03/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/10/2016
• 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