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

Model Number	502-030-14
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/26/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: NAKED-DRIVER
• Manufacturer (Section D): SPINEEX, INC.; 4046 clipper court; fremont CA 94538
• MDR Report Key: 8596566
• Report Number: 3013758617-2019-00001
• Device Sequence Number: 2192954
• Product Code: MAX
• UDI-Device Identifier: 00819837020507
• UDI-Public: 00819837020507
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K190193
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Biomedical Engineer
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 04/25/2019

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: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2019
• Initial Report FDA Received Date: 05/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR