MAUDE Adverse Event Report: DEPUY SYNTHES SPINE VIPER2 T20 HEXLOBE DRIVER SHAF; DRIVER, PROSTHESIS

Catalog Number 286725020

Device Problems Break (1069); Detachment Of Device Component (1104)

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

Event Date 11/30/2017

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Device is available for evaluation.Investigation will be conducted.Follow up will be filed with the investigation results.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Upon insertion of the s1 pedicle screw , the head of the viper screw popped off.We retrieved the broken screw, then placed a larger size to replace it.Dr.(b)(6) the attempted to back out the new screw and then the hexalobe driver tip broke off.

Manufacturer Narrative

Product complaint # (b)(4).Device received at investigation site.

Manufacturer Narrative

Product complaint # (b)(4).Visual inspection of the returned device found the distal tip was broken off.An optical image, of the fracture surfaces reveals plastic deformation at the hexlobes and torsional shear markings following a circular pattern.This suggests the driver underwent a quasi-static overload 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.The root cause cannot be determined from the information provided.However, fracture analysis suggests the driver underwent a quasi-static overload 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 T20 HEXLOBE DRIVER SHAF
• Type of Device: DRIVER, PROSTHESIS
• 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 ; 5088808100
• MDR Report Key: 7121687
• MDR Text Key: 95191388
• Report Number: 1526439-2017-50088
• Device Sequence Number: 1
• Product Code: HWR
• UDI-Device Identifier: 10705034214290
• UDI-Public: 10705034214290
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• 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,Followup
• Report Date: 11/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 286725020
• Device Lot Number: SO2023954
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/30/2017
• Initial Date FDA Received: 12/15/2017
• Supplement Dates Manufacturer Received: 11/30/2017; 01/26/2018
• Supplement Dates FDA Received: 01/17/2018; 01/29/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/17/2016
• 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
• Patient Age: 36 YR
• Patient Weight: 120