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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ARTICULAR SURFACE PROVISIONAL SZ 5 9MM; TEMPLATE
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SMITH & NEPHEW, INC. ARTICULAR SURFACE PROVISIONAL SZ 5 9MM; TEMPLATE Back to Search Results
Catalog Number 00584102509
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 03/27/2019
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that during surgery the tibial insert trial broke.The procedure was completed using a backup device with no delays.
 
Additional Manufacturer Narrative
Reviewing the information received by the manufacturer has identified that this event should be re-evaluated for mdr reporting.The information states that the trial broke but there is no confirmation that the device broke inside the patient´s incision, 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
ARTICULAR SURFACE PROVISIONAL SZ 5 9MM
Common Device Name
TEMPLATE
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key8512747
Report Number1020279-2019-01564
Device Sequence Number19278603
Product Code HWT
UDI-Device Identifier00885556619575
UDI-Public00885556619575
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
EXEMPT
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 11/13/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Catalogue Number00584102509
Initial Date Received by Manufacturer 03/27/2019
Supplement Date Received by Manufacturer03/27/2019
Initial Report FDA Received Date04/15/2019
Supplement Report FDA Received Date11/13/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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