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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 VELYS SAW BLADE INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

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DEPUY IRELAND - 9616671 VELYS SAW BLADE INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT Back to Search Results
Model Number 4515-70-000
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Unspecified Tissue Injury (4559)
Event Date 04/04/2022
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
Surgeon started velys ras attune ps primary knee after completion of all initialization, calibration and draping as per the ifu. Natural joint assessment and planning was then completed and the surgeon chose to perform a 2 degree varus cut on the tibia. The knee was positioned with 'z' retractors placed medial and lateral to protect the collateral ligaments. After finishing the cut with an osteotome the sensor tensor was then used to check balance with the accubalance graph. It was then noted an unexpected increase in medial laxity relative to the lateral compartment. After further assessment it was identified that the mcl was damaged and need repair with fibrewire. This was completed and the femoral cuts were completed with navigation. The rest of the case proceeded without further delay or incident. Doe: (b)(6) 2022.
 
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Brand NameVELYS SAW BLADE
Type of DeviceINSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork
EI
Manufacturer (Section G)
DEPUY ORTHOPAEDICS INC 1818910
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer Contact
kate karberg
700 orthopaedic dr.
warsaw, IN 46581-0988
3035526892
MDR Report Key14186364
MDR Text Key289863914
Report Number1818910-2022-07286
Device Sequence Number1
Product Code OLO
UDI-Device Identifier10603295519140
UDI-Public10603295519140
Combination Product (y/n)N
Reporter Country CodeAS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 04/22/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/22/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number4515-70-000
Device Catalogue Number451570000
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/06/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/22/2022 Patient Sequence Number: 1
Treatment
ATTUNE PS FEM RT SZ 4 NAR CEM
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