MAUDE Adverse Event Report: DEPUY SYNTHES SPINE VIPER2 SELF-DRILLING TAP; BONE TAP

Catalog Number 286715500

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 08/27/2014

Event Type  malfunction  

Event Description

International affiliate reports that during tapping before screw insertion at t12, the tip of the viper2 self-drilling tap broke off.When reversing the broken tip to remove it using an extraction screw owned by the hospital, the broken tip was then broken in half.Since it was difficult to remove completely, the surgeon left the broken piece in the patient¿s body and finished the operation.According to the afflliate, the patient had hard bone due to the administration of a medicine before surgery and it may be a possible cause of the failure.

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 viper2, 5mm self-drilling tap revealed that the fracture was located at about 20mm from the tap¿s distal tip.Optical images of the fractured surface reveal plastic deformation and torsional shear markings following a circular pattern around the cannulation.This shows evidence of a quasi-static torsional shear failure that is extended around the center of the shaft.No material defects or other abnormalities were observed in this analysis.Review of the device history record found no discrepancies.Product was released accomplishing all quality requirements.A review of the complaint trend analysis was performed and no systemic trend was identified as a result of the analysis.The root cause of the breakage cannot positively be determined.However, it was identified in the fracture analysis report that the fractured surface shows evidence of a quasi-static torsional shear failure that is extended around the center of the shaft.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 have been observed, 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: VIPER2 SELF-DRILLING TAP
• Type of Device: BONE TAP
• 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: 4102075
• MDR Text Key: 4756668
• Report Number: 1526439-2014-11910
• Device Sequence Number: 1
• Product Code: HWX
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 286715500
• Device Lot Number: 0210NG
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2014
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 10/22/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/02/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1