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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GNS II P/S REAMER SHAFT HANDLE; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
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SMITH & NEPHEW, INC. GNS II P/S REAMER SHAFT HANDLE; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL Back to Search Results
Catalog Number 71440464
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 12/11/2018
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that the handle broke in half during surgery.
 
Additional Manufacturer Narrative
The associated complaint device was not returned.A clinical evaluation was conducted and no relevant clinical medical information was provided to conduct a thorough medical assessment.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.
 
Event or Problem Description
It was reported that the handle broke in half during surgery.No delay.No impact or injury to patient reported.No confirmation of backup was received.
 
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Brand Name
GNS II P/S REAMER SHAFT HANDLE
Common Device Name
PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key8214778
Report Number1020279-2019-00039
Device Sequence Number19531077
Product Code JDG
UDI-Device Identifier03596010215628
UDI-Public03596010215628
Combination Product (Y/N)N
Initial Reporter StateAZ
Initial Reporter CountryUS
PMA/510(K) Number
K123598
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) 03/27/2019
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 Number71440464
Initial Date Received by Manufacturer 12/11/2018
Supplement Date Received by Manufacturer12/11/2018
Initial Report FDA Received Date01/03/2019
Supplement Report FDA Received Date03/27/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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