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

MAUDE Adverse Event Report: DEPUY IRELAND VELYS SAW INTERFACE RIGHT 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 IRELAND VELYS SAW INTERFACE RIGHT ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Model Number 4515-70-106
Device Problem Device Slipped (1584)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/11/2022
Event Type  malfunction  
Event Description
This is report 3 of 3 for the same event. It was reported that during a total knee arthroplasty surgical procedure, it was observed that the robotic assisted saw assembly saw interface left (sasi) clamp was loose and not performing the primary function. It was reported that the cut on the tibia could not be made and there was a lot of shutting down and stopping. It was reported that looking at the saw clamp it had no pressure and took little to no pressure to lift it up and not enough force to stay latched. It was also reported that two right sasi clamps seemed to lack the capacity to stay locked properly and could pop loose during surgeries as well, and had the same latching weakness as the left sasi. It was reported that there were no delays in the surgical procedure and the case was successful. There was patient involvement. There were no injuries, medical intervention or prolonged hospitalization. All available information has been disclosed. If additional information should become available, a supplemental medwatch will be submitted accordingly.
 
Manufacturer Narrative
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. Additional narrative: as of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated. Concomitant medical devices and therapy dates, robotic assisted saw assembly saw interface left device, (b)(6), 2022. Udi:(b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameVELYS SAW INTERFACE RIGHT
Type of DeviceORTHOPEDIC STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
DEPUY IRELAND
loughbeg ringaskiddy co.
cork
EI
Manufacturer Contact
kate karberg
700 orthpaedic dr.
warsaw, IN 46581
3035526892
MDR Report Key14251925
MDR Text Key290449692
Report Number1818910-2022-07153
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K202769
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/20/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/29/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number4515-70-106
Device Catalogue Number451570106
Device Lot NumberJ44455
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Date Manufacturer Received05/05/2022
Was Device Evaluated by Manufacturer? No
Date Device Manufactured07/19/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

-
-