MAUDE Adverse Event Report: DEPUY SPINE INC VIPER SYSTEM CORTICAL FIX POLYAXIAL SCREW 5.5 8 X 50MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number	186731850
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Device report from synthes reports an event in japan as follows: it was reported that the patient underwent a transforaminal interbody fusion (l4/5) on (b)(6) 2023.After surgery, adjacent segment disease occurred, and a revision surgery was performed on (b)(6) 2023.In the revision surgery, screws at l4/5 were removed, l4-5 intervertebral discs were dissected, a cage was inserted, and a pps (percutaneous pedicle screw) (l3-5) was performed.After inserting the cage, screws were inserted into both sides of l3, and another screw was inserted into the right side of l4.At this time, originally a 7mm diameter cfs was in place, so the screw hole was widened with 8mm diameter and the cfs 8mm screw was inserted percutaneously using the universal poly screwdriver.But the patient¿s bone quality was hard, and the universal poly screwdriver seemed to get idled at the end of the insertion.Therefore, the sales rep asked the surgeon to remove the universal poly screwdriver.It was found that the tip of the universal poly screwdriver was missing when it was checked.It was assumed that the tip of the universal poly screwdriver remained in the screw core of the cfs 8mm screw, and although attempts were made to remove the cfs 8mm screw itself, the cfs 8mm screw could not be removed using any method, so the surgeon gave up removing the cfs 8mm screw.The surgeon inserted another screw into another place, set rods, and completed the procedures.The surgery was completed successfully with a 60-minute delay.This report involves one viper system cortical fix polyaxial screw 5.5 8 x 50mm.This is report 2 of 2 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: d2b: additional device product codes: mni, mnh, kwq , kwp.D9: complainant part is not expected to be returned for manufacturer review/investigation.E3: reporter is a j&j employee.H3, h4, h6: 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.

• Brand Name: VIPER SYSTEM CORTICAL FIX POLYAXIAL SCREW 5.5 8 X 50MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 17867756
• Report Number: 1526439-2023-01895
• Device Sequence Number: 17899517
• Product Code: NKB
• UDI-Device Identifier: 10705034352206
• UDI-Public: (01)10705034352206
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K160904
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup

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 Catalogue Number: 186731850
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/15/2023
• Supplement Date Received by Manufacturer: 11/16/2023
• Initial Report FDA Received Date: 10/04/2023
• Supplement Report FDA Received Date: 12/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN CAGE/SPACER; VIPER UNIVERSAL POLY DRIVER
• Patient Sex: Unknown