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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 04/11/2022
Event Type  malfunction  
Event Description
It was reported that during a total knee arthroscopy procedure, it was observed that the robotic assisted saw interface left clamp that connects the saw handpiece was reported to be loose. It was reported that there were no delays in the procedure and no cancellations. 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. 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 INTERFACE LEFT
Type of DeviceORTHOPEDIC STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
DEPUY IRELAND
loughbeg ringaskiddy co.
cork
EI
Manufacturer (Section G)
DEPUY SYNTHES PRODUCTS LLC
4500 riverside drive
palm beach gardens FL
Manufacturer Contact
kate karberg
700 orthpaedic dr.
warsaw, IN 46581
3035526892
MDR Report Key14115421
MDR Text Key289319636
Report Number1818910-2022-06802
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 04/14/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/14/2022
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 Received05/19/2022
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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