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Catalog Number 03.835.032
Device Problem Failure to Align (2522)
Patient Problem No Code Available (3191)
Event Date 08/31/2016
Event Type  Injury  
Manufacturer Narrative
Patient weight was not provided. (b)(4). Device is an instrument and is not implanted / explanted. Complainant part is not expected to be returned for manufacturer review/investigation. Concomitant devices reported: unknown protection sleeve (part# unknown, lot# unknown, quantity 1), unknown screwdriver (part# unknown, lot# unknown, quantity 1), unknown handle with quick coupling (part# unknown, lot# unknown, quantity 1), thread lock sleeve (part# 03. 835. 009s, lot# 9916325, quantity 1), lock screw, fine tip, 20mm (part# 04. 835. 120. 02s, lot# 9911949, quantity 1), lock screw, fine tip, 25mm (part# 04. 835. 125. 02s, lot# 9912685, quantity 2), synfix evolution spacer, medium (part# 08. 815. 222s, lot# 9848673, quantity 1), aiming device (part# 08. 815. 222s, lot# 9848673, quantity 1). Therapy date: (b)(6) 2016. (b)(4). Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer. Device history records review could not be completed without lot number. Device 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 Description
It was reported that on (b)(6) 2016, a patient underwent procedure to implant a synfix evolution device at l5-s1. After attaching the aiming guide to the implant, while attempting to awl the first hole at l5, the surgeon could not penetrate the patient's vertebral body. Under fluoroscopy, the surgeon confirmed that the awl was getting caught in the aiming guide and would not advance into the l5 vertebral body. Multiple attempts were made to perforate the cortex of the vertebral body but were unsuccessful. The surgeon tried to place the screw, but was unsuccessful due to the failure of the awl to create a pathway. The surgeon made the decision to leave the synfix evolution spacer implanted and achieved fixation with an anterior lumbar plate. A surgical delay of approximately thirty (30) minutes was reported. Surgery was completed successfully with patient outcome deemed as successful. This report is for one (1) synfix evolution awl/without sleeve. This is report 1 of 1 for (b)(4).
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Type of DeviceAWL
Manufacturer (Section D)
1302 wrights lane east
west chester PA 19380
Manufacturer Contact
mark vornheder
1302 wrights lane east
west chester, PA 19380
MDR Report Key5955919
MDR Text Key54922440
Report Number2520274-2016-14547
Device Sequence Number1
Product Code HWJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 08/31/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/16/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number03.835.032
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/31/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 09/16/2016 Patient Sequence Number: 1