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

Model Number	87134
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tip of the driver broke off during a case.The tip was retrieved.
Additional Manufacturer Narrative
The device has not returned for investigation.Photographs were not provided; therefore, the complaint cannot be confirmed.The lot number was not provided; therefore, a review of device history records cannot be performed.Based on the information provided, the root cause is unknown.If the device and/or additional information is provided, a supplemental report will be filed accordingly.
Additional Manufacturer Narrative
Corrected information: d4.Model #: 87034, catalog #: 87034, lot #: 7405603.D9.Yes, returned to manufacturer on 07/01/2024.H3.Yes.The driver that was returned for investigation was a different part than was initially reported.This driver does not require an mdr submission.
Additional Manufacturer Narrative
Additional information: added patient id.Corrected information: the driver that was returned for investigation was a different part than was initially reported.

• 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: 19484115
• Report Number: 2027467-2024-00057
• Device Sequence Number: 7905995
• Product Code: HXX
• UDI-Device Identifier: 00840967197906
• UDI-Public: (01)00840967197906
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Followup
• Report Date (Section B): 06/06/2024

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: 87134
• Device Catalogue Number: 87134
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2024
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 06/07/2024
• Supplement Report FDA Received Date: 07/17/2024; 07/17/2024
• 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
• Patient Sex: Unknown