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

Model Number 279734000N

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/20/2022

Event Type  Injury  

Manufacturer Narrative

The subject device has been received, the investigation is in progress, no conclusion could be drawn at the time of filing this report. Device was used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that on (b)(6) 2021 during posterior spinal fusion procedure, while placing a viper xtab screw in lumbar pedicles l5 and l4. The tips of both kick 2d brainlab screwdrivers sheared off. Attempt was made to remove sheared off tips but both were embedded inside the internal hex of the screw. Rod could lay flush and tighten down completely so surgeon made decision to leave the screws in as patient had hard bone and surgeon did not want to risk fracturing a pedicle while trying to remove. There was a surgical delay of thirty (30) minutes. The procedure was successfully completed. This report is for one (1) 5. 5 viper univ poly driver. This is report 2 of 2 for complaint (b)(4).

• Brand Name: 5.5 VIPER UNIV POLY DRIVER
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 13559567
• MDR Text Key: 285831008
• Report Number: 1526439-2022-00246
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 10705034388410
• UDI-Public: (01)10705034388410
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140927
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 279734000N
• Device Catalogue Number: 279734000N
• Device Lot Number: GM5358808
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/22/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown

Patient Treatment Data

Date Received: 02/18/2022 Patient Sequence Number: 1

Treatment

UNK - MONO/POLYAXIAL SCREWS: VIPER; UNK - RODS: VIPER