MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH SYNFIX® EVOLUTION AIMING DEVICE HOLDER; IMPACTOR

Catalog Number 03.835.004

Device Problem Device-Device Incompatibility (2919)

Patient Problems Injury (2348); No Code Available (3191)

Event Date 04/02/2019

Event Type  Injury  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2019, the patient underwent an anterior spinal fusion procedure using with synfix evolution system.During the procedure, an unknown implant was inserted with a correctly attached synfix evolution aiming device holder and synfix evolution aiming device, but the coupling for aiming device holder remained inside.When the coupling was removed, the coupling screwdriver was not removed by pulling counter counterclockwise when it was still engaged with the holder.It was only released when the surgeon pulled the coupling screwdriver.The surgeon did not recognize due to the counterclockwise turning, it loosened the coupling screw and aiming device where the implant was no longer fully fixed.As a result, during subsequent pilot hole creation and screw insertion, the trajectory was not 100% correct due to the loosened aiming device.Once the surgeon got aware of the root cause he removed all screws, tightened the aiming device on the implant again and re-inserted all screws without any further problems.The procedure was successfully completed with an unspecified number of minutes of surgical delay.There was no patient consequence reported.The surgeon recommended to adapt the surgical technique with a "precaution" or "warning" that during removal of the coupling screwdriver it must not be turned counter-clockwise, but just simple pulled.Concomitant device reported: unknown synfix implant (part # unknown, lot # unknown, quantity unknown), synfix evolution aiming device (part # 03.835.001, lot # unknown, quantity of 1).This report is for one (1) synfix® evolution aiming device holder.This is report 2 of 4 for complaint (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Product was not returned, however the input / recommendation from the surgeon was forwarded to the responsible product development center (pdc).Abstract from pdc statement: in the surgical technique it is simply and clearly shown how the coupling screwdriver has to be removed.There is one arrow in one direction only that indicates that the device must simply be pulled out without turning.In the complaint description it is stated the device was turned counterclockwise and therefore not performed according to the surgical technique.In addition, according to the complaint description nothing was damaged, and the handling only was the reason for raising a complaint.A more-in-detail investigation cannot be performed, since the involved items have not been returned.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventive action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 AIMING DEVICE HOLDER
• Type of Device: IMPACTOR
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8579380
• MDR Text Key: 144015331
• Report Number: 8030965-2019-63481
• Device Sequence Number: 1
• Product Code: HWA
• UDI-Device Identifier: 07611819677043
• UDI-Public: (01)07611819677043
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.835.004
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/08/2019
• Initial Date FDA Received: 05/03/2019
• Supplement Dates Manufacturer Received: 06/11/2019
• Supplement Dates FDA Received: 06/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SYNFIX EVOLUTION AIMING DEVICE 10.5+12; UNK - CAGE/PLATE: SYNFIX EVOLUTION; SYNFIX EVOLUTION AIMING DEVICE 10.5+12; UNK - CAGE/PLATE: SYNFIX EVOLUTION
• Patient Outcome(s): Required Intervention