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U.S. Department of Health and Human Services

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

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DEPUY IRELAND VELYS SAW INTERFACE LEFT ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Model Number 4515-70-105
Device Problem Device Slipped (1584)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/16/2022
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. Additional narrative: as of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated. Udi: (b)(4). Concomitant medical devices and therapy dates, saw interface device, saw handpiece device, base station and satellite station device. (b)(6) 2022.
 
Event Description
This is report 1 of 3 for the same event. It was reported that during a total knee arthroscopy surgical procedure, it was observed that the robotic assisted saw handpiece device was stuttering on every cut. It was reported that there was play between the saw interface right (sasi) and the saw handpiece. The reporter stated that the devices were swapped out. The reporter stated that the surgeon ¿touched up¿ the tibia after the swap out. Swapping out the saw interface and the saw handpiece resolved the observed stuttering. After the surgical procedure, it was reported that the left saw interface and the saw handpiece were tested and it was observed that there was even more play between the device. It was reported that the surgeon manually completed the cuts. It was reported that there was a 5 to 10 minute delay in the surgical procedure. It was reported that the devices were being used with a robotic assisted base station and satellite station device. There was patient involvement. There were no reports of 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 LEFT
Type of DeviceORTHOPEDIC STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
DEPUY IRELAND
loughbeg ringaskiddy co.
cork
EI
Manufacturer Contact
kara ditty-bovard
700 orthpaedic dr.
warsaw, IN 46581
6107428552
MDR Report Key13863192
MDR Text Key288677664
Report Number1818910-2022-05183
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 Health Professional,User Facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/22/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/23/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number4515-70-105
Device Catalogue Number451570105
Device Lot NumberJ44180
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received05/20/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/21/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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