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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. T6 DRIVER SHAFT W/AO QC; SCREWDRIVER
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SMITH & NEPHEW, INC. T6 DRIVER SHAFT W/AO QC; SCREWDRIVER Back to Search Results
Catalog Number 71174921
Device Problem Packaging Problem (3007)
Patient Problem No Patient Involvement (2645)
Event Date 05/22/2020
Event Type  malfunction  
Event Description
It was reported that upon inspection the box label code was mistaken.The instruments inside the box were different, the actual products inside were 71174821, with batch lot 18mup0006.There was no case involved.The event was an out of the box failure.
 
Manufacturer Narrative
Additional information received by the manufacturer has identified that this event should be re-evaluated for mdr reporting.The new information states the failure was found during inspection and there are no previous serious events for this malfunction, 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
T6 DRIVER SHAFT W/AO QC
Type of Device
SCREWDRIVER
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis TN 38116
MDR Report Key10173137
MDR Text Key195718875
Report Number1020279-2020-02594
Device Sequence Number1
Product Code HXX
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 06/21/2020
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
Device Operator Health Professional
Device Catalogue Number71174921
Device Lot Number18MUP0006A
Initial Date Manufacturer Received 05/22/2020
Initial Date FDA Received06/19/2020
Supplement Dates Manufacturer Received05/22/2020
Supplement Dates FDA Received06/21/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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