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

Model Number 279734000N

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/23/2020

Event Type  malfunction  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. The investigation could not be completed; no conclusion could be drawn, as no product was received. Based on the information available, it has been determined that no corrective and/or preventative action is proposed. This complaint will be accounted for, and monitored via post market surveillance activities. If additional information is made available, the investigation will be updated as applicable. 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) 2020, during an unknown procedure, the surgeon prepared the patient's l5 pedicle on the left side for pedicle screw placement. The surgeon tapped the prepared pathway with the 6. 0mm tap and determined the appropriate screw size. The surgeon requested the 7. 0x45mm screw, which the surgical tech loaded on the corresponding navigation driver. The surgeon commented on the patient's strong bone quality and suggested following the 6. 0 tap with the 7. 0 tap to further prepare the pathway. The surgeon determined it was not necessary and proceeded with his screw placement. As he advanced the pedicle screw down the pedicle with minimal resistance. At approximately 40-45mm into pedicle screw placement, the surgeon encountered significant resistance and on the final turn of the driver, the tip broke off in the recess of the pedicle screw. The surgeon was able to retrieve the broken tip, and he was satisfied with the position of the pedicle screw. The broken driver was removed from the sterile field and replaced with a new driver. The procedure continued without further incident. There was no surgical delay. Fragments were generated, and easily removed. There were no patient consequences. The procedure was successfully completed. Concomitant device reported: 5. 5 ti cort fix 7x45mm (part# 1867-31-745, lot# unknown, quantity unknown); 6mm dual-lead tap (part# 2797-02-600n, lot# unknown, quantity unknown); 7mm dual-lead tap (part# 2797-02-700n, lot# unknown, quantity unknown). This report is for one (1) 5. 5 viper univ poly driver. This is report 1 of 1 for (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 (Section G): BRIDGEWATER DISTRIBUTION; 50 scotland boulevard; bridgewater MA 02324
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 10863485
• MDR Text Key: 217696410
• Report Number: 1526439-2020-02228
• Device Sequence Number: 1
• Product Code: OLO
• 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,health

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 10/23/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 11/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 279734000N
• Device Catalogue Number: 279734000N
• Device Lot Number: GM5358811
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2020
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 11/24/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/09/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown