MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TI VECTRA(TM) PLATE 3 LEVEL/51MM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number	04.613.251
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter is a synthes sales consultant.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 or Problem Description
It was reported that on an unknown date, during an unknown procedure, the inner locking mechanism of a vectra 51 mm 3 level plate sheared off while inserting a self-drilling variable angle screw.There were fragments generated from broken device.The fragment was secured.The procedure was successfully completed with no surgical delay.Patient status is unknown.Concomitant device: self-drilling variable angle screw (part/lot unknown, quantity unknown).This report is for a vectra 51 mm 3 level plate.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.H3, h6: investigation summary complaint summary: 6/25/2019: updated event description: it was reported that on (b)(6) 2019, during an unknown procedure, the inner locking mechanism of a vectra 51mm 3 level plate sheared off while inserting a self-drilling variable angle screw.There were fragments generated from broken device.The fragment was secured.The procedure was successfully completed with no surgical delay.There was no impact to the patient.Concomitant device reported: unk - screws: spine-us (part # unknown, lot # unknown, quantity unknown).This complaint involves one (1) device.Flow: damage visual inspection: the picture of the titanium vectra plate 3 level/ 51 mm (part # 04.613.251, lot unknown) was received at us cq showing one of the locking mechanisms that broke off from the plate.This is consistent with the reported complaint condition, thus confirming the complaint.As the implant was not returned an as received, dimensional, material or drawing reviews are not applicable.A manufacturing record evaluation was not performed since the lot number is unknown.Conclusion: there is no indication that a design or manufacturing issue contributed to the complaint.While no definitive root cause could be determined it is possible that the device encountered unintended forces.No new malfunctions were observed during the course of this investigation.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.

• Brand Name: TI VECTRA(TM) PLATE 3 LEVEL/51MM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8727405
• Report Number: 2939274-2019-58822
• Device Sequence Number: 2221002
• Product Code: KWQ
• UDI-Device Identifier: 10705034737423
• UDI-Public: (01)10705034737423
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K050451
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2019

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: 04.613.251
• Device Catalogue Number: 04.613.251
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/07/2019
• Supplement Date Received by Manufacturer: 06/25/2019
• Initial Report FDA Received Date: 06/24/2019
• Supplement Report FDA Received Date: 07/18/2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - SCREWS; UNK - SCREWS