MAUDE Adverse Event Report: SYNTHES USA SYNFIX® EVOLUTION AWL/WITHOUT SLEEVE

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).

• Brand Name: SYNFIX® EVOLUTION AWL/WITHOUT SLEEVE
• Type of Device: AWL
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5955919
• MDR Text Key: 54922440
• Report Number: 2520274-2016-14547
• Device Sequence Number: 1
• Product Code: HWJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• 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 Received: 09/16/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 03.835.032
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/31/2016
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 32 YR