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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. VISIONAIRE JII FEMORAL CUTTING BLOCK; PATIENT MATCHED TECHNOLOGY
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SMITH & NEPHEW, INC. VISIONAIRE JII FEMORAL CUTTING BLOCK; PATIENT MATCHED TECHNOLOGY Back to Search Results
Catalog Number V0100080
Device Problem Material Too Rigid or Stiff (1544)
Patient Problem Tissue Damage (2104)
Event Date 07/25/2016
Event Type  Injury  
Manufacturer Narrative
Customer indicated that there is no product/device to be returned for investigation analysis.
 
Event Description
It was reported additional cuts were made on the femur due to cutting block being too tight.
 
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Brand Name
VISIONAIRE JII FEMORAL CUTTING BLOCK
Type of Device
PATIENT MATCHED TECHNOLOGY
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
Manufacturer (Section G)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
Manufacturer Contact
yagna angirish
1450 brooks rd
memphis, TN 38106
9013985146
MDR Report Key5875580
MDR Text Key52091442
Report Number1020279-2016-00627
Device Sequence Number1
Product Code JWH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K082358
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 07/25/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/15/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date09/29/2016
Device Catalogue NumberV0100080
Device Lot Number00051392V1
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/25/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/01/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Other;
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