Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ARTICULAR SURFACE PROVISIONAL SZ 3 8MM; TEMPLATE
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SMITH & NEPHEW, INC. ARTICULAR SURFACE PROVISIONAL SZ 3 8MM; TEMPLATE Back to Search Results
Catalog Number 00584102308
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 03/12/2019
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that during surgery the item broke in half.No injuries or delays reported.No more information presented.
 
Additional Manufacturer Narrative
This complaint has been re-evaluated for mdr reporting.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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ARTICULAR SURFACE PROVISIONAL SZ 3 8MM
Common Device Name
TEMPLATE
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key8493599
Report Number1020279-2019-01457
Device Sequence Number19323376
Product Code HWT
UDI-Device Identifier00885556619445
UDI-Public00885556619445
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) 06/03/2019
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 Number00584102308
Device Lot Number63258922
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/08/2019
Initial Date Received by Manufacturer 03/12/2019
Supplement Date Received by Manufacturer03/12/2019
Initial Report FDA Received Date04/08/2019
Supplement Report FDA Received Date06/03/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
-
-