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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SYN F/T BRCH SZ 14; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
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SMITH & NEPHEW, INC. SYN F/T BRCH SZ 14; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED Back to Search Results
Catalog Number 71366714
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code No Information (3190)
Date of Event 04/03/2017
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported the surgery was extended past 30 minutes.While the broach was in the canal, the top of the broach sheared off during extraction attempt from broach handle.
 
Additional Manufacturer Narrative
Add'l info.
 
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Brand Name
SYN F/T BRCH SZ 14
Common Device Name
PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key6522609
Report Number1020279-2017-00298
Device Sequence Number13545440
Product Code JDI
UDI-Device Identifier03596010429674
UDI-Public03596010429674
Combination Product (Y/N)N
Initial Reporter StateVT
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 Physician
Type of Report Initial,Followup
Report Date (Section B) 05/26/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Catalogue Number71366714
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/21/2017
Type of Report(Section G)FDA Requested
Initial Date Received by Manufacturer 04/03/2017
Supplement Date Received by ManufacturerNot provided
Initial Report FDA Received Date04/26/2017
Supplement Report FDA Received Date05/26/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
Patient Age65 YR
Patient Weight75
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