MAUDE Adverse Event Report: DEPUY SYNTHES SPINE VIPER2 SET SCREW INSERTER, SELF-RETAINING; SCREWDRIVER

Catalog Number 286735400

Device Problem Torn Material (3024)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/09/2015

Event Type  malfunction  

Event Description

During the final tightening of the set screw the surgeon wanted to remove and replace the inner set screw.He used the set screw inserter to try and remove the inner set screw.The thread of the inner set screw inserter broke off in the set screw and was not able to be retrieved.It was left in the set screw.Tried a broke screw removal set to try and retrieve the broken threaded portion of set screw inserter.

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

One (1) viper2 x25 setscrew inserter [product code: 2867-35-400, lot no: ag2098445] was returned to the complaints handling unit (chu) for evaluation.Visual examination revealed that the fracture was located at the inserter¿s distal tip, the second half of the tip was not provided for 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.No emerging trends were found requiring further actions.The fracture analysis report revealed plastic deformation and twisting of each self-retaining tab suggesting the inserter tips underwent a quasi-static torsional overload shear failure.No material defects or other abnormalities were observed in this analysis.The root cause for the setscrew inserter¿s distal tip becoming broken cannot be positively determined.However, the fracture analysis report reveals plastic deformation and twisting of each self-retaining tab suggesting the inserter tips underwent a quasi-static torsional overload 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 requiring immediate action 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 SET SCREW INSERTER, SELF-RETAINING
• 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: michael jacene ; 325 paramount drive; raynham, MA 02767 ; 5089776485
• MDR Report Key: 4883293
• MDR Text Key: 6017524
• Report Number: 1526439-2015-10597
• Device Sequence Number: 1
• Product Code: HXX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 286735400
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2015
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 07/27/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1