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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY UNI TIBIAL IMPACTOR; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
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SMITH & NEPHEW, INC. JRNY UNI TIBIAL IMPACTOR; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER Back to Search Results
Catalog Number 71441353
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/10/2018
Event Type  malfunction  
Event Description
It was reported that impactor broke during surgery, back-up device used, no pieces were left in patient.Delay greater than 30 min, but less than a hour.
 
Manufacturer Narrative
Additional information received by the manufacturer has identified that this event should be re-evaluated for mdr reporting.The new information states that the delay in the surgery was less than 30 min, therefore, it was determined that this case does not meet the threshold for reporting and is a non-reportable event.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.
 
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Brand Name
JRNY UNI TIBIAL IMPACTOR
Type of Device
PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key8046267
MDR Text Key126415138
Report Number1020279-2018-02388
Device Sequence Number1
Product Code HSX
UDI-Device Identifier03596010588050
UDI-Public03596010588050
Combination Product (y/n)N
PMA/PMN Number
K113038
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 12/03/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/07/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number71441353
Device Lot Number17DM12487
Was Device Available for Evaluation? No
Date Manufacturer Received11/06/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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