MAUDE Adverse Event Report: SYNTHES USA SYNFIX® EVOLUTION SCREW/25MM STERILE; INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION, LUMBAR

Catalog Number 04.835.225.02S

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/16/2017

Event Type  malfunction  

Manufacturer Narrative

Device used for treatment, not diagnosis.Patient age & weight not provided for reporting.The 04.835.225.02s, device product code was not located, however in jde: ovd.(b)(4).Device malfunctioned intra-operatively and was not implanted / explanted.Device is not expected to be returned for manufacturer review/investigation.Without a lot number, the device history record review and the investigation could not be completed; no conclusion could be drawn, as no product was received.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 a patient underwent an anterior lumbar interbody fusion (alif) on (b)(6) 2017.As the surgeon was putting in one of the screws, the tip of the screwdriver broke off and got stuck in the tip of the screw.The surgeon was able to remove it and threw it away.Standard x-ray revealed no further fragments.Patient was implanted with synfix evolution stand alone, four synfix 25mm screws ¿ surgeon was on the fourth screw when the tip broke and used a different screwdriver to finish the case.There was a five (5) to ten (10) minute delay, another screwdriver was readily available.Surgery was successfully completed and patient was stable.This complaint involves 2 devices concomitant devices reported: screws (part # unknown, lot # unknown, quantity two (2)).This report is 2 of 2 for (b)(4).

Manufacturer Narrative

The initial complaint was reviewed and found not reportable.Sales consultant later confirmed that there is no allegation against screw.This information was reassessed and determined to be not reportable.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.

• Brand Name: SYNFIX® EVOLUTION SCREW/25MM STERILE
• Type of Device: INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION, LUMBAR
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6455237
• MDR Text Key: 71729751
• Report Number: 2520274-2017-11167
• Device Sequence Number: 1
• Product Code: OVD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150673
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/16/2017

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
• Device Operator: Health Professional
• Device Catalogue Number: 04.835.225.02S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/16/2017
• Initial Date FDA Received: 04/03/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: SCREWS (PART # UNKNOWN, LOT # UNKNOWN,QTY 2
• Patient Age: 45 YR