MAUDE Adverse Event Report: DEPUY SYNTHES SPINE 5.5 VIPER UNIV POLY DRIVER; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number 279734000N

Event Date 12/19/2017

Event Type  malfunction  

Manufacturer Narrative

(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

During the procedure the surgeon was inserting pelvic screws.He tapped for the prior to the insertion of the screw.He then begain inserting the screw and approximately half way during the insertion the stress of the torque exerted on to the driver cause it to sheer off in the head of screw.We promptly removed the screw and tapped again.We then loaded up another screw and again had the same issue.And again removed the screw.

Manufacturer Narrative

Product complaint # (b)(4).Visual inspection showed that the distal tip was fracture.Device was sent for fracture analysis.An optical image of the driver¿s fractured surface, reveals plastic deformation at the hex lobes 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.However, based on device evaluation, a potential root cause may be due to wear and tear or 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: 5.5 VIPER UNIV POLY DRIVER
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): MEDOS INTERNATIONAL SARL; chemin blanc 38; le locle ; CH
• Manufacturer Contact: jason busch ; 325 paramount drive; raynham, MA 02767 ; 5088808100
• MDR Report Key: 7185681
• MDR Text Key: 97085653
• Report Number: 1526439-2018-50042
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 10705034388410
• UDI-Public: 10705034388410
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120867
• 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
• Report Date: 12/19/2017

1 Device 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: 279734000N
• Device Lot Number: GM4690401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/19/2017
• Initial Date FDA Received: 01/12/2018
• Supplement Dates Manufacturer Received: 01/18/2018
• Supplement Dates FDA Received: 01/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/29/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown