MAUDE Adverse Event Report: SPINEEX, INC. SAGITTAE; NAKED-DRIVER

Model Number 502-030-14

Device Problems Break (1069); Off-Label Use (1494); Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/26/2019

Event Type  malfunction  

Manufacturer Narrative

This specific revision of this driver instrument is not intended to be used without a special spineex provided handle with a maximum torque limit of 2.25 n*m.The instrument was used without the correct 2.25 n*m torque limiting handle provided by spineex by the choice of the surgeon operating.Note: the reason for a two week delay in submission of this 30-day report from the day of the event ((b)(6) 2019) is due to technical difficulties in setting up a new webtrader account for spineex with the emdr team.The report was ready for submission as of 25-apr-2019 (30 calendar days from the reportable event).The cdrh emdr team was made aware of this delay due to technical difficulties surrounding setting up an esg webtrader account, and instructed this statement to be placed within this section of the report for reference.[(b)(4)].

Event Description

A spineex driver instrument malfunctioned during surgery when used improperly without the required spineex 2.25 n*m torque limiting handle.During step 7 of the sagittae surgical technique, dr.(b)(6) was using the spineex sagittae naked-driver to expand the anterior and posterior sides of the sagittae implant independently of one another.He was using the spineex 2.25 n*m torque limiting handle to do so.When he was unable to get all the desired torque, he was then looking for other methods to expand the posterior side of the implant, he asked for a non-torque limiting t-handle not provided by spineex to connect to the spineex sagittae naked-driver in hopes of obtaining more torque.Spineex representatives reminded dr.(b)(6) that the sagittae naked-driver was not intended to be used without the spineex provided 2.25 n*m torque limiting handle.Dr.(b)(6) understood this and still requested for the non-spineex provided non-torque limiting t-handle.Upon connecting the non-torque limiting t-handle to the sagittae naked driver, he proceeded to apply a torque in the wrong direction (counterclockwise) to the posterior side of the implant.(b)(6) instructed him he was applying the torque in the incorrect direction.He then reversed the direction of the torque to the correct direction (clockwise) and then sheared the torx t10 tip of the sagittae naked driver off in the implant that was already inserted into the patient.The tip remained attached to the implant.Dr.(b)(6) then used a pituitary rongeur to retrieve the tip from the implant and did so immediately without any harm to the patient.

• Brand Name: SAGITTAE
• Type of Device: NAKED-DRIVER
• Manufacturer (Section D): SPINEEX, INC.; 4046 clipper court; fremont CA 94538
• Manufacturer (Section G): SPINEEX, INC.; 4046 clipper court; fremont CA 94538
• Manufacturer Contact: andrew rogers ; 4046 clipper court; fremont, CA 94538 ; 5105736165
• MDR Report Key: 8596566
• MDR Text Key: 145635695
• Report Number: 3013758617-2019-00001
• Device Sequence Number: 1
• Product Code: MAX
• UDI-Device Identifier: 00819837020507
• UDI-Public: 00819837020507
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190193
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Biomedical Engineer
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 04/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 502-030-14
• Device Catalogue Number: 502-030-14
• Device Lot Number: 181129H1FG
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/29/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/29/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 63 YR