MAUDE Adverse Event Report: DEPUY SYNTHES SPINE VIPER POLYAXIAL DRIVER; SCREWDRIVER

Catalog Number 286760010

Device Problem Torn Material (3024)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

Thread breakage on the viper polyaxial driver was noted during expresscare inspection by depuy synthes spine.It is not known where/where thread breakage occurred and the location of the broken thread is unknown.There had been no report of any adverse consequences to a patient or delay.However, as it is possible that a torn thread could be left in a patient, a medwatch report is being submitted to document the event.

Manufacturer Narrative

A follow up report will be filed upon completion of the investigation.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Visual examination of the returned device revealed that the first two rows of threads on the poly driver¿s shaft, which interface on the poly screw¿s tulip head threads, had become sheared off.A review of the device history record (dhr) for the viper x-tab 10mm poly driver was conducted.No issues were identified in the manufacturing and release of this device that could have contributed to the problem reported by the customer.A trend analysis was conducted.No emerging trends were found requiring further actions.The root cause cannot positively be determined.It is not known where the threads becoming sheared off occurred and the location of which this fault happened is unknown.The shearing of the threads was noted during expresscare inspection by depuy synthes spine.As there has been no issue identified in the manufacturing or release of the device that could have contributed to the problem reported by the customer and no systemic trends were found, this complaint file will be closed with no further action required.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: VIPER POLYAXIAL DRIVER
• Type of Device: SCREWDRIVER
• Manufacturer (Section D): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: anita barnick ; 325 paramount drive; raynham, MA 02767 ; 5088283583
• MDR Report Key: 4329971
• MDR Text Key: 5245817
• Report Number: 1526439-2014-12214
• Device Sequence Number: 1
• Product Code: HXX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 286760010
• Device Lot Number: MI20255
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/15/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/11/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1