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 01/03/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Sales rep called into customer quality to report a tap broke during surgery.Tip was left in the patient.Surgeon was performing a l4-5 mis tlif.When tapping the left l4 pedicle, the 6.0mm tap broke at the thread / shaft junction while in the pedicle.The portion was not retrieved and remained in the patient.

Manufacturer Narrative

Udi: (b)(4).Visual examination of the returned device revealed that the tap was fractured at the instrument¿s threaded working end.The second half of the broken tap was not provided as it remained in the patient.Device was then sent for fracture analysis.The fracture analysis report suggests that the tap underwent a quasi-static torsional shear failure.No material defects or other abnormalities were observed in this analysis.A review of the device history record was conducted.No issues were identified during the manufacturing and release of this product that could have contributed to the problem reported by the customer.A trend analysis was conducted.No emerging trends were found requiring further actions.A definitive root cause for the tap breaking cannot be positively determined.However, the fracture analysis report suggests that the tap underwent a quasi-static torsional shear failure.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: 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: jason busch ; 325 paramount drive; raynham, MA 02767 ; 5088808201
• MDR Report Key: 6289141
• MDR Text Key: 66122656
• Report Number: 1526439-2017-10061
• Device Sequence Number: 1
• Product Code: HWX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 286715600
• Device Lot Number: NG36329
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/27/2012
• 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