MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC SYNFIX® EVOLUTION AIMING DEVICE/13.5MM & 15MM; INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION, LUMBAR

Model Number	03.835.002
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter is synthes sales consultant.Without a lot number the device history records review could not be completed.Customer quality conducted an investigation of the returned device.Device evaluation: investigation flow: broken and device interaction/functional visual inspection: the spindle for evolution (03.825.002) was received lodged in the synfix evaluation trial spacer holder (03.835.100) with a synfix evolution trial spacer (03.835.223) attached at the distal end.The knob of the spindle was broken at the weld which secures it to the shaft and was received detached.Additional surface wear consistent with use was noted which would not impact device functionality.As the complaint allegation related to an inability to disassemble the construct, the received condition was found to agree with the complaint description; the additional failure related to a broken weld was identified during the investigation.The devices were found during sterile processing, as such the specific circumstances at the time of the issue are unknown, therefore, it cannot be definitively determined if external factors (use error, misuse/abuse, etc.) impacted the complaint condition.Functional test: the construct was unable to be disassembled due to the broken spindle knob, as such the complaint condition was both able to be confirmed and replicated.Dimensional inspection: inspection of the relevant feature, the weld, was unable to be completed due to post manufacturing damage.Document/specification review: as the lot number is unknown, review of drawings from the time of manufacture is not possible.The following drawings, reflecting the current revision, were reviewed: spindle assembly, implant holder: spindle, implant holder: knob, trial spacer handle: during the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.Material review: a material and/or hardness review was not possible as a review of the device history record(s) was not possible as the device¿s lot number is unknown.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Conclusion the complaint condition is confirmed as the spindle was unable to be disassembled from the trialing construct (03.835.100, 03.835.002 and 03.835.223).During investigation it was additionally identified that the spindle knob was broken from the device¿s shaft at the weld.Although a definitive root cause could not be determined, it is likely that this complaint condition is due to excessive force applied to the spindle during attempted disassembly as a result of the spindle being cross-threaded into the trial.During this investigation no product design or manufacturing issues were observed that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed 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 or Problem Description
It was reported that on (b)(6) 2018, it was noticed during inspection at loaners department that the synfix evolution aiming device was stuck in synfix evolution trial spacer holder.There was no patient involvement.Evaluation of the returned device revealed the spindle on the aiming device is broken.This report is for one (1) synfix evolution aiming device.This is report 1 of 1 for (b)(4).

• Brand Name: SYNFIX® EVOLUTION AIMING DEVICE/13.5MM & 15MM
• Common Device Name: 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: 8199475
• Report Number: 2939274-2018-55600
• Device Sequence Number: 2154579
• Product Code: OVD
• UDI-Device Identifier: 10705034814070
• UDI-Public: (01)10705034814070
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K150673
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/27/2018

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
• Operator of Device: Health Professional
• Device Model Number: 03.835.002
• Device Catalogue Number: 03.835.002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/27/2018
• Initial Report FDA Received Date: 12/27/2018
• Patient Sequence Number: 1