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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. T-HANDLE; PROSTHESISHIPFEMORACOMPONENTCEMNTDMTAL
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SMITH & NEPHEW, INC. T-HANDLE; PROSTHESISHIPFEMORACOMPONENTCEMNTDMTAL Back to Search Results
Model Number OR71364006
Device Problem Break (1069)
Patient Problem No Information (3190)
Event Date 11/05/2019
Event Type  malfunction  
Event Description
It was reported that during a thr procedure, plastic handle broke while reaming.Delay form (0-30) minutes reported.Backup device available.No impact or injury to patient reported.
 
Manufacturer Narrative
This event should be re-evaluated for mdr reporting.Reviewing the information available it was determined that the device broke outside of the patient, 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
T-HANDLE
Type of Device
PROSTHESISHIPFEMORACOMPONENTCEMNTDMTAL
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key9398731
MDR Text Key168802533
Report Number1020279-2019-04247
Device Sequence Number1
Product Code JDG
UDI-Device Identifier03596010199225
UDI-Public03596010199225
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Type of Report Initial,Followup
Report Date 02/03/2020
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 Model NumberOR71364006
Device Catalogue NumberOR71364006
Device Lot Number15DSY0032
Initial Date Manufacturer Received 11/05/2019
Initial Date FDA Received12/02/2019
Supplement Dates Manufacturer Received12/05/2019
Supplement Dates FDA Received02/03/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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