MAUDE Adverse Event Report: DEPUY SYNTHES SPINE VIPER2 6MM SELF DRILLING TAP; TAP, BONE

Catalog Number 286715600

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 06/03/2014

Event Type  malfunction  

Event Description

International affiliate reports that during the procedure when using the viper2 self-drilling tap prior to screw insertion, the tap snapped and left a large fragment within the patient's pedicle/vertebral body.The difficulty resulted in a delay of approximately ten minutes to the procedure.

Manufacturer Narrative

A complaint investigation will be performed.The complaint product is not available for the investigation.A supplemental report is not anticipated unless the results of the complaint investigation identify a corrective action or additional relevant information.Should the product become available, a physical evaluation will be conducted and a supplemental report filed with the results.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Not available for evaluation.

Manufacturer Narrative

As indicated on the initial mfg.Medwatch report 1526439-2014-11632, the viper2 6mm self-drilling tap was not returned for evaluation.Review of the device history record could not be performed as the lot number was not provided.Without a lot number, review of the manufacturing records cannot be completed.Complaint trending was performed and no immediate product action is required.An internal data review has been opened to review design control documentation and similar failures will be monitored as a part of post market surveillance activities.Without the self-drilling tap, we are unable to confirm the reported issue or identify the root cause.No corrective and preventive action is necessary at this time as we are unable to confirm the reported issue.Therefore, this complaint will be closed with no further action required.If the instrument sample becomes available, the complaint will be reopened and the instrument will be evaluated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: VIPER2 6MM SELF DRILLING TAP
• Type of Device: TAP, BONE
• 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: 3894792
• MDR Text Key: 21966435
• Report Number: 1526439-2014-11632
• 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: 06/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 286715600
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 07/17/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1