MAUDE Adverse Event Report: DEPUY SPINE INC VIPER UNIVERSAL POLY DRIVER; SCREWDRIVER

Catalog Number 279734000

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

Patient Problems Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/23/2024

Event Type  malfunction  

Event Description

Device report from synthes reports an event in japan as follows: it was reported that this was a posterior spinal fusion for degenerative spondylolisthesis on (b)(6) 2024.The tip of the screwdriver in question broke off because of the high force required when inserting the screw due to osteosclerosis.The debris was completely buried within the screw core.Because of the strong screw and the risk of fracture, the surgeon decided not to remove the debris then to connect the rods.The surgery was completed successfully within 30 minutes surgical delay.This report is for one (1) viper universal poly driver.This is report 1 of 1 for complaint (b)(4).

Manufacturer Narrative

Product complaint # (b)(4).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: e3: reporter is a j&j employee.D9: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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.

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: d4: expiration date added e1: initial reporter's phone number added h3,h4,h6 the device associated with this report was returned to depuy synthes for evaluation.Visual analysis of the returned sample revealed that tip of the device is broken.Broken fragment was not returned for analysis.Furthermore threads of the device show signs of damage.There is no evidence provided to confirm foreign body left in patient.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces while usage of the device.A dimensional inspection was unable to be performed due to post manufactured damage.The overall complaint was confirmed as the observed condition of the viper universal poly driver would have contribute to the complained device issue.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.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Drawing/specifications reviewed the following source controlled drawings reflecting the current and manufactured revisions were reviewed: dgw 887007888 rev.D (current and manufactured).Dimensional inspection: n/a h4, h6 a review of the receiving inspection (ri) for viper universal poly driver was conducted identifying that lot number mi69951 released in one batch.Batch1: lot units were released oct 25, 2018 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.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.D4: lot number updated d9: device returned.

• Brand Name: VIPER UNIVERSAL POLY DRIVER
• Type of Device: SCREWDRIVER
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; chemin-blanc 38; le locle ; SZ ; 3035526892
• MDR Report Key: 18645813
• MDR Text Key: 334667480
• Report Number: 1526439-2024-00820
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/05/2024

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: MI69951
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/23/2024
• Initial Date FDA Received: 02/05/2024
• Supplement Dates Manufacturer Received: 02/08/2024; 03/08/2024
• Supplement Dates FDA Received: 02/20/2024; 03/20/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/25/2018
• 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