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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND VELYS SAW HANDPIECE INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

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DEPUY IRELAND VELYS SAW HANDPIECE INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT Back to Search Results
Model Number 4515-70-102
Device Problem Device Slipped (1584)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/13/2022
Event Type  malfunction  
Event Description
It was reported that prior to a total knee arthroplasty procedure, that is was observed that there was "play" in the area where the robotic assisted saw handpiece device connected to the saw interface device. It was reported that multiple saw interface devices were tried but it was observed that the "play" was still there. The saw handpiece device was replaced and it was reported that there was there was no more "play". There was no 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. Udi: (b)(4).
 
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Brand NameVELYS SAW HANDPIECE
Type of DeviceINSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
Manufacturer (Section D)
DEPUY IRELAND
loughbeg ringaskiddy co.
cork
EI
Manufacturer Contact
kate karberg
700 orthpaedic dr.
warsaw, IN 46581
3035526892
MDR Report Key14251822
MDR Text Key290449333
Report Number1818910-2022-07245
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
Report Date 04/21/2022
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 Number4515-70-102
Device Catalogue Number451570102
Was Device Available for Evaluation? No
Date Manufacturer Received04/13/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/11/2022
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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