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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 20DEG 36MM TRIAL 54MM; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
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SMITH & NEPHEW, INC. R3 20DEG 36MM TRIAL 54MM; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE Back to Search Results
Catalog Number 71367954
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 01/29/2019
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that a small piece of the instrument broke during surgery.The broken piece was recovered.No injuries or delays reported.
 
Additional Manufacturer Narrative
The associated complaint device was not returned.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.
 
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Brand Name
R3 20DEG 36MM TRIAL 54MM
Common Device Name
INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key8380039
Report Number1020279-2019-00878
Device Sequence Number14174978
Product Code MDM
UDI-Device Identifier03596010599889
UDI-Public03596010599889
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
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) 06/13/2019
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 Number71367954
Initial Date Received by Manufacturer 01/29/2019
Supplement Date Received by Manufacturer01/29/2019
Initial Report FDA Received Date02/28/2019
Supplement Report FDA Received Date06/13/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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