• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

DEPUY SPINE INC 5.5 VIPER UNIV POLY DRIVER ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
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).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name5.5 VIPER UNIV POLY DRIVER
Type of DeviceORTHOPEDIC 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 Key10863485
MDR Text Key217696410
Report Number1526439-2020-02228
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K120867
Number of Events Reported1
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 Received11/18/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number279734000N
Device Catalogue Number279734000N
Device Lot NumberGM5358811
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/24/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/24/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/09/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

-
-