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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ARTICULAR SURFACE PROVISIONAL SZ 2 8MM; TEMPLATE
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SMITH & NEPHEW, INC. ARTICULAR SURFACE PROVISIONAL SZ 2 8MM; TEMPLATE Back to Search Results
Catalog Number 00584102208
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 02/15/2019
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that during surgery the sz 2, 8mm trial cracked upon insertion.The trial was slightly cracked so was still able to use it, and a back-up device was no needed.The procedure was completed satisfactory without delays.
 
Additional Manufacturer Narrative
The associated complaint device was not returned.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.We consider this investigation closed.
 
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Brand Name
ARTICULAR SURFACE PROVISIONAL SZ 2 8MM
Common Device Name
TEMPLATE
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key8401548
Report Number1020279-2019-00991
Device Sequence Number312390
Product Code HWT
UDI-Device Identifier00885556619384
UDI-Public00885556619384
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 Physician
Type of Report Initial,Followup
Report Date (Section B) 06/20/2019
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 Number00584102208
Initial Date Received by Manufacturer 02/15/2019
Supplement Date Received by Manufacturer02/15/2019
Initial Report FDA Received Date03/07/2019
Supplement Report FDA Received Date06/20/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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