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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 11.5 X 44 130 D TAN LT LIME ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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SMITH & NEPHEW, INC. 11.5 X 44 130 D TAN LT LIME ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 71647344
Device Problem Device Expiration Issue (1216)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/01/2016
Event Type  malfunction  
Event Description
It was reported to us from the hospital that during an emergency case (add on) a tan nail was used and contained an expired date. Product has been implanted into the patient and is in situ.
 
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Brand Name11.5 X 44 130 D TAN LT LIME
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
Manufacturer (Section G)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
Manufacturer Contact
claudia odoy
schachenallee 29
aarau 5001
SZ   5001
0628320660
MDR Report Key6003052
MDR Text Key57253671
Report Number1020279-2016-00774
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K040462
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/15/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/06/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/01/2016
Device Catalogue Number71647344
Device Lot Number06FM01525
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/26/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/01/2006
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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