MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC SYNFIX® EVOLUTION FINE TIP SCREW/25MM - STERILE; INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION, LUMBAR

Model Number	04.835.125.02S
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: exact date of event is unknown.Device available for evaluation: device is not expected to be returned for manufacturer review/investigation.(b)(4).Device evaluated by mfr, manufacture date: product was not returned.Device history records review could not be completed without lot number.Based on the information available, it has been determined that no corrective and 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 or Problem Description
It was reported that patient underwent initial surgery on (b)(6) 2019.On (b)(6) 2019, the patient underwent hardware removal of two (2) synfix evolution screw that backed out.The screw was completely backed up and no synfix evolution instruments were needed to revise the surgery.The screw was floating.They left the three other screws and cage implanted in the patient and only pulled out the loose screw that backed out.There was no surgical delay.The procedure was completed successfully.Patient status was stable.Concomitant device: torque handle: (part unknown, lot unknown, quantity 1).Cage/.Spacers: syncage (part unknown, lot unknown, quantity 1).This report is for one (1) synfix evolution screw.This is report 1 of 1 for (b)(4).
Additional 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.Actual device was not returned.Review of received photograph confirmed the condition of a screw which has backed out of a cage in situ.The x-ray image clearly shows that one (1) screw is no longer secured or contacting the cage.A review of the device history records was unable to be performed since the lot number is unknown.Relevant drawing was reviewed.No product design issues or discrepancies were observed during this investigation.A definitive assignable root cause for the screw migrating/backing out post operative could not be determined based on the provided information.This complaint is confirmed however no product design issues or manufacturing discrepancies that would contribute to the reported complaint condition were identified during this investigation.No new, unique or different patient harms were identified as a result of this evaluation.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 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 FINE TIP SCREW/25MM - STERILE
• 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: 8492976
• Report Number: 2939274-2019-57366
• Device Sequence Number: 16633087
• Product Code: OVD
• UDI-Device Identifier: 20705034816125
• UDI-Public: (01)20705034816125
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K150673
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2019

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
• Operator of Device: Health Professional
• Device Model Number: 04.835.125.02S
• Device Catalogue Number: 04.835.125.02S
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/13/2019
• Supplement Date Received by Manufacturer: 05/09/2019
• Initial Report FDA Received Date: 04/08/2019
• Supplement Report FDA Received Date: 05/10/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 42 YR
• Patient Weight: 73