MAUDE Adverse Event Report: DEPUY SPINE INC VIPER SYSTEM POLYAXIAL SCREW DRIVER T20; SCREWDRIVER

Catalog Number 279734000

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Insufficient Information (4580)

Event Date 09/15/2023

Event Type  malfunction  

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: d9: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.E3: reporter is a j&j employee.H3, h6: the investigation could not be completed; no conclusion could be drawn, as no product was received.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 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 polyaxial screw driver t20.This is report 1 of 2 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: a review of the receiving inspection (ri) for viper universal poly driver, was conducted identifying that lot number tbaiob was released in one batch.Batch1: lot qty of (b)(4) units were released on 30 aug 2019 with no discrepancies.Supplier: micropulse incorporated.As a result, the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that the tip of viper universal poly driver was broken.The broken fragment was not returned for evaluation.The allegation of embedded device was not confirmed as no post operative images were provided to evaluate the condition.Based on the observed condition of the device, the investigation was able to confirm the reported vent.No other problem identified.A dimensional inspection was not performed as it is not applicable to the complaint condition.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed condition of the viper universal poly driver would contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.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.If information is obtained that was not available for this medwatch, a follow-up medwatch will be filed as appropriate.D4: lot # updated.

• Brand Name: VIPER SYSTEM POLYAXIAL SCREW DRIVER T20
• Type of Device: SCREWDRIVER
• 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: 17867759
• MDR Text Key: 324877119
• Report Number: 1526439-2023-01894
• Device Sequence Number: 1
• Product Code: HXX
• UDI-Device Identifier: 10705034200279
• UDI-Public: (01)10705034200279
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,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
• Device Operator: Health Professional
• Device Catalogue Number: 279734000
• Device Lot Number: TBAIOB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/15/2023
• Initial Date FDA Received: 10/04/2023
• Supplement Dates Manufacturer Received: 10/13/2023; 11/16/2023
• Supplement Dates FDA Received: 10/26/2023; 12/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/30/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 5.5 TI CORT FIX 8X50MM.; UNKNOWN CAGE/SPACER.