MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC SYNFIX EVOLUTION FINE TIP SCREW/20MM - STERILE; INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION, LUMBAR

Model Number	04.835.120.02S
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that on (b)(6) 2020, patient underwent a & p lumbar fusion procedure, while instrumenting l4-l5 one of our synfix evolution fine tip screws/20mm sterile torqued out early.When placing the next screw, they were unable to advance it all the way down.The surgery spent approximately fifteen (15) minutes trying to remove the screw that would not advance.However, they noticed that the screw could not advance because the previous screw was not completely down.The surgeon drove the screw to the torqued early down and was able to advance the other screw.It is unknown if the procedure was completed successfully.There was no patient consequence reported.Concomitant device reported: unknown screwdriver: (part# unknown, lot# unknown, quantity 1).This complaint involves one (1) device.This report is for (1) synfix® evolution fine tip screw/20mm - sterile.This is report 1 of 2 for (b)(4).

• Brand Name: SYNFIX EVOLUTION FINE TIP SCREW/20MM - STERILE
• Common Device Name: INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION, LUMBAR
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10382036
• Report Number: 2939274-2020-03431
• Device Sequence Number: 3528578
• Product Code: OVD
• UDI-Device Identifier: 20705034816118
• UDI-Public: (01)20705034816118
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K150673
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/17/2020

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: 04.835.120.02S
• Device Catalogue Number: 04.835.120.02S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/17/2020
• Initial Report FDA Received Date: 08/07/2020
• Patient Sequence Number: 1
• Patient Age: 67 YR