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

Model Number 87771

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/18/2020

Event Type  malfunction  

Manufacturer Narrative

The returned instrument is currently being evaluated.A follow up report with results of the investigation will be submitted upon completion.

Event 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.

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
• Type of Device: ALPHATEC NAVIGATION SURGICAL INSTRUMENTS
• Manufacturer (Section D): ALPHATEC SPINE INC; 5818 el camino real; carlsbad CA 92008
• MDR Report Key: 10546610
• MDR Text Key: 208178161
• Report Number: 2027467-2020-00041
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00190376002965
• UDI-Public: (01)00190376002965(10)7825203R1R2
• Combination Product (y/n): N
• PMA/PMN Number: K153603
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 08/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 08/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other