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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 Problem Device Slipped (1584)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/10/2021
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.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.
 
Event Description
It was reported that during a surgical procedure, it was observed that excessive movement was experienced with the robotic-assisted saw solution saw interface right device and the array was not visible.The case was completed with no issues.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.Additional narrative: 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.
 
Event Description
It was reported that during a surgical procedure, it was observed that excessive movement was experienced with the robotic-assisted saw solution saw interface right device and the array was not visible.The case was completed with no issues.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
Product complaint # (b)(4).Investigation summary: after multiple requests, the customer has not returned the device for evaluation / repair to any jnj site and therefore the complaint cannot be confirmed, and no conclusion can be drawn at this time.The complaint will be reopened upon receiving the device for repair from the customer.Device history lot: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.
 
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Brand Name
VELYS SAW INTERFACE RIGHT
Type of Device
ORTHOPEDIC 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 Key13060581
MDR Text Key286065136
Report Number1818910-2021-28230
Device Sequence Number1
Product Code OLO
UDI-Device Identifier10603295519478
UDI-Public10603295519478
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 Other
Type of Report Initial
Report Date 12/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/22/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number4515-70-106
Device Catalogue Number451570106
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received03/14/2022
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 Unknown
Patient Sequence Number1
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