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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DIRECT MEASURE 4.0MM; PLATE, FIXATION, BONE
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SMITH & NEPHEW, INC. DIRECT MEASURE 4.0MM; PLATE, FIXATION, BONE Back to Search Results
Catalog Number 71117083
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 08/12/2019
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that the ruler broke during procedure.No injuries or delays reported.Backup device available.
 
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.
 
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Brand Name
DIRECT MEASURE 4.0MM
Common Device Name
PLATE, FIXATION, BONE
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key8977796
Report Number1020279-2019-03320
Device Sequence Number18888625
Product Code HRS
UDI-Device Identifier03596010173898
UDI-Public03596010173898
Combination Product (Y/N)N
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) 09/18/2019
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 Number71117083
Device Lot Number50610173
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/28/2019
Initial Date Received by Manufacturer 08/12/2019
Supplement Date Received by Manufacturer08/12/2019
Initial Report FDA Received Date09/09/2019
Supplement Report FDA Received Date09/18/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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