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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND UC VELYS ARRAY CLAMP ORTHOPEDIC STEREOTAXIC INSTRUMENT

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DEPUY IRELAND UC VELYS ARRAY CLAMP ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Model Number 4515-70-107
Device Problems Mechanical Problem (1384); Premature Separation (4045)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/03/2022
Event Type  malfunction  
Event Description
This is report 4 of 5 for the same event. It was reported that during a surgical procedure, it was observed the femoral cuts were off while the satellite station device was in use. Following the surgery, it was reported that the clinician pulled on the femoral arrays and observed that the array devices detached from the array clamps without pressing the button release on the array clamp devices. It was reported that there were a total of four array clamps that released the array without pressing the button. There was patient involvement. There were no reports of injuries, medical intervention or prolonged hospitalization and the surgery was completed successfully. All available information has been disclosed. Multiple attempts have been made to obtain additional information. No additional information has been received. 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). Concomitant medical devices and therapy dates, array clamp devices and satellite station device, (b)(6) 2022.
 
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). Concomitant medical devices and therapy dates, array clamp devices and satellite station device, (b)(6) 2022.
 
Event Description
This is report 4 of 5 for the same event. It was reported that during a surgical procedure, it was observed the femoral cuts were off while the satellite station device was in use. Following the surgery, it was reported that the clinician pulled on the femoral arrays and observed that the array devices detached from the array clamps without pressing the button release on the array clamp devices. It was reported that there were a total of four array clamps that released the array without pressing the button. There was patient involvement. There were no reports of injuries, medical intervention or prolonged hospitalization and the surgery was completed successfully. All available information has been disclosed. Multiple attempts have been made to obtain additional information. No additional information has been received. If additional information should become available, a supplemental medwatch will be submitted accordingly.
 
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Brand NameVELYS ARRAY CLAMP
Type of DeviceORTHOPEDIC 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 Key13621293
MDR Text Key286275604
Report Number1818910-2022-03768
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,Followup
Report Date 02/28/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/28/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number4515-70-107
Device Catalogue Number451570107
Device Lot NumberJ43054
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Date Manufacturer Received05/18/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/22/2021
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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