MAUDE Adverse Event Report: ALPHATEC SPINE INC ARSENAL SPINAL FIXATION SYSTEM; ALPHATEC NAVIGATION SURGICAL INSTRUMENTS

Model Number	87771
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The returned instrument is currently being evaluated.A follow up report with results of the investigation will be submitted upon completion.
Event or Problem Description
The distal tip of an arsenal navigation driver sheared off while attempting to inserter a screw.The detached section was removed but was discarded.
Additional Manufacturer Narrative
An evaluation of the returned polyaxial screwdriver found that the distal tip had fractured and became separated from the instrument.Inspection under magnification revealed circular fracture lines indicative of a torsional overload.Alphatec spine navigated reusable instruments are intended to be used during the preparation and placement of alphatec screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures.

• Brand Name: ARSENAL SPINAL FIXATION SYSTEM
• Common Device Name: ALPHATEC NAVIGATION SURGICAL INSTRUMENTS
• Manufacturer (Section D): ALPHATEC SPINE INC; 5818 el camino real; carlsbad CA 92008
• MDR Report Key: 10546610
• Report Number: 2027467-2020-00041
• Device Sequence Number: 14201162
• Product Code: OLO
• UDI-Device Identifier: 00190376002965
• UDI-Public: (01)00190376002965(10)7825203R1R2
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K153603
• 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): 08/21/2020

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: 87771
• Device Catalogue Number: 87771
• Device Lot Number: 7825203R1R2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2020
• Initial Date Received by Manufacturer: 08/21/2020
• Supplement Date Received by Manufacturer: 08/21/2020
• Initial Report FDA Received Date: 09/17/2020
• Supplement Report FDA Received Date: 10/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other