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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HUMERAL SCREW DEPTH GAUGE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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SMITH & NEPHEW, INC. HUMERAL SCREW DEPTH GAUGE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 71751139
Device Problem Illegible Information (4050)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/05/2019
Event Type  malfunction  
Event Description
It was reported that during surgery the humeral screw depth gauge is worn off.Measurements could not be obtained during the procedure because the writing on the device could not read.There was no harm to the patient or the staff.S+n back up was available and used to complete the case.Replacement needed.
 
Manufacturer Narrative
Additional information received by the manufacturer has identified that this event should be re-evaluated for mdr reporting.After a re-evaluation of the information provided it was determined that the device was not used and a s&n backup was used to finish the surgery, therefore, it 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
HUMERAL SCREW DEPTH GAUGE
Type of Device
ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key9529994
MDR Text Key177208829
Report Number1020279-2019-04630
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
PMA/PMN Number
K122170
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 01/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/30/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number71751139
Date Manufacturer Received01/24/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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