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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND UC VELYS SAW INTERFACE RIGHT ORTHOPEDIC STEREOTAXIC INSTRUMENT

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DEPUY IRELAND UC VELYS SAW INTERFACE RIGHT ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Model Number 4515-70-106
Device Problems Device Slipped (1584); Premature Separation (4045)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/04/2022
Event Type  malfunction  
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. The actual device has been returned and is currently pending evaluation. Once the evaluation has been completed, a supplemental medwatch report will be sent accordingly. Concomitant medical devices and therapy dates, saw handpiece device, (b)(6) 2022. Udi: (b)(4).
 
Event Description
This is report 1 of 2 for the same event. It was reported that during the procedure and while making the anterior femoral cut, the robotic assisted saw interface right (sasi) device was loose and not clamping tight to the saw handpiece device. It was further observed that the saw handpiece was connecting loosely to the sasi. It was further reported that the right sasi came unlatched during the cut and it was clamped back quickly with no impact to surgery. It was reported that the sasi was tested with other saw handpiece devices and found the connection to be loose. Additionally, the saw handpiece was tested with other sasi's and found the connection to be loose. Other sasi's with the other saw handpiece device clamped securely. It was reported that there were no delays in the surgical procedure. 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.
 
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Brand NameVELYS SAW INTERFACE RIGHT
Type of DeviceORTHOPEDIC STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
DEPUY IRELAND UC
loughbeg ringaskiddy co.
cork
EI
Manufacturer Contact
kara ditty-bovard
700 orthpaedic dr.
warsaw, IN 46581
6107428552
MDR Report Key13384453
MDR Text Key284621857
Report Number1818910-2022-00705
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 Company Representative,Distributor
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/27/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/28/2022
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 NumberJ44179
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/18/2022
Is the Reporter a Health Professional? No
Date Manufacturer Received02/21/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/21/2021
Is the Device Single Use? No
Type of Device Usage Unkown

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