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U.S. Department of Health and Human Services

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

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DEPUY IRELAND UC VELYS SAW HANDPIECE INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT Back to Search Results
Model Number 4515-70-102
Device Problem Premature Separation (4045)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/02/2022
Event Type  malfunction  
Manufacturer Narrative
Device was used for treatment, not diagnosis. As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated. The device serial or lot number was unknown; therefore, udi: (b)(4). Unknown. Device manufacture date is unknown. The device serial or lot number is unknown. Concomitant medical devices and therapy dates, robotic assisted satellite station and array set, (b)(6) 2022. 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 during a total knee arthroscopy procedure and while in the middle of making the femur cuts, the array device "popped" off of the robotic assisted saw handpiece near the blade. It was reported that the device was also being used with a robotic assisted satellite station. It was further reported that it was verified the array attached into the saw properly by hearing and feeling it click into place. 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 HANDPIECE
Type of DeviceINSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
Manufacturer (Section D)
DEPUY IRELAND UC
loughbeg ringaskiddy co.
cork
EI
Manufacturer Contact
amy hendrickson
700 orthpaedic dr.
warsaw, IN 46581
5743674841
MDR Report Key13953873
MDR Text Key288288521
Report Number1818910-2022-05832
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 03/30/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/30/2022
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 Received03/02/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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