MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC SYNFIX® EVOLUTION AIMING DEVICE/17MM & 19MM; INTERVERTEBRAL FUSION DEVICE W/ INTEGRATED FIXATION, LUMBAR

Model Number 03.835.003

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The device was received, the investigation is in progress, 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 Description

It was reported that on an unknown date, during a routine incoming inspection, it was observed that the synfix evolution aiming device was broken.There was no patient involvement.This complaint involves one (1) device.This report is for one (1) synfix® evolution aiming.This is report 1 of 1 for (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.Visual inspection: the synfix® evolution aiming device holder (part # 03.835.004 / lot # 1l83789) was received at us cq assembled with synfix® evolution aiming device/17mm & 19mm (part # 03.835.003/ lot # 9910647).The two devices were unable to disassemble.The aiming device does not sit flush with the device holder.The devices were aligned correctly based on the alignment etches.The device holder was jammed and cannot be engaged to release the aiming device.There was no evidence of physical device breakage.The reported condition of broken was not confirmed.Functional test: functional testing with the returned devices showed that the aiming device holder was not able to be pushed proximally and was jammed in the received state.Due to jammed condition of the device holder, the device was not able to release the aiming device thus the devices were unable to disassemble.The device was functionally broken thus the overall complaint was confirmed.Can the complaint be replicated with the returned device(s)? yes; as-received state cannot be undone.Devices do not disassemble.Dimensional inspection: due to the aiming device not sitting flush with the device holder, a diameter of the mating shaft could be measured.Specified dimension: shaft outer diameter = 7.4mm +/-.05mm.Measured dimension: shaft outer diameter = 7.38mm; conforming.Device used: ca818.Document/specification review: drawing(s) reviewed: (current & manufactured revisions).[device holder].[aiming device].Conclusion: the overall complaint was confirmed for the received synfix® evolution aiming device/17mm & 19mm (part # 03.835.003/ lot # 9910647) as the device was unable to disassemble with the received device holder, thus the device was functionally broken.Although no definitive root-cause can be determined, it is possible that the components experienced unintended forces leading to an internal mechanical failure.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history part: 03.835.003-us.Lot: 9910647.Manufacturing site: hägendorf.Release to warehouse date: 22.July 2016.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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/17MM & 19MM
• Type of Device: 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: 9280725
• MDR Text Key: 167175794
• Report Number: 2939274-2019-61983
• Device Sequence Number: 1
• Product Code: OVD
• UDI-Device Identifier: 10705034814094
• UDI-Public: (01)10705034814094
• Combination Product (y/n): N
• PMA/PMN Number: K150673
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 10/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03.835.003
• Device Catalogue Number: 03.835.003
• Device Lot Number: 9910647
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2019
• Date Manufacturer Received: 12/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1