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

Model Number 279734000

Device Problem Break (1069)

Patient Problems Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/01/2022

Event Type  Injury  

Event Description

Device report from synthes reports an event in japan as follows: it was reported that this was a removal procedure (foreign object in the spine) and a posterior lumbosacral spine fusion at s1 right on (b)(6) 2022.The poly driver in question was attached to a screw extension.When the surgeon tried to insert a screw (186731840) with the poly driver, the driver¿s tip broke off.A fragmented tip stuck to the screw¿s core.The procedure was completed without surgical delay.No further information is available.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).Investigation summary: product was not returned.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 history lot: a review of the receiving inspection (ri) for viper universal poly driver was conducted identifying that serial number (b)(4) was released in one batch.Batch 1: lot qty of (b)(4) units was released on 06 feb 2013 with no discrepancies.Supplier: (b)(4).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.

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.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.A review of the receiving inspection (ri) for viper universal poly driver was conducted identifying that serial number (b)(6) was released in one batch.Batch 1: lot units was released on 06 feb 2013 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 has broken, the broken was not returned.No other problems were observed.A dimensional inspection was not performed for the viper universal poly driver due to post manufacturing damage.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to excessive/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.Drawing/specifications reviewed: rev e current, rev b manufactured.Dimensional inspection: n/a.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 UNIVERSAL POLY DRIVER
• Type of Device: SCREWDRIVER
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 15127118
• MDR Text Key: 296844784
• Report Number: 1526439-2022-01300
• 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: 07/28/2022

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
• Device Operator: Health Professional
• Device Model Number: 279734000
• Device Catalogue Number: 279734000
• Device Lot Number: MI27190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/01/2022
• Initial Date FDA Received: 07/28/2022
• Supplement Dates Manufacturer Received: 08/26/2022; 09/21/2022
• Supplement Dates FDA Received: 09/20/2022; 10/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/06/2013
• 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 8X40MM
• Patient Outcome(s): Required Intervention