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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. META-TAN LAG/COMP KIT 95/90 ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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SMITH & NEPHEW, INC. META-TAN LAG/COMP KIT 95/90 ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 71642695
Device Problem Off-Label Use (1494)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/11/2018
Event Type  malfunction  
Event Description
It was reported that the surgeon was performing a trigen intertan and was given a trigen meta- tan lag compression screw. The packaging for both is identical apart from the words intertan and meta-tan. The other screws fitted onto the intertan equipment and it was only on closer looking at the x ray which that the surgeons realized their mistake. No patient injury as this was recognised intraoperatively and exchanged for the correct screws. Both screws were implanted then removed and the correct screws were put in.
 
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Brand NameMETA-TAN LAG/COMP KIT 95/90
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
sarah freestone
1450 brooks road
memphis, TN 38116
MDR Report Key8046265
MDR Text Key126411479
Report Number1020279-2018-02409
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K092748
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/18/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/07/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number71642695
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 Received10/12/2018
Was Device Evaluated by Manufacturer? No
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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