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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. META-TAN 11.5MM X 42CM LEFT ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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SMITH & NEPHEW, INC. META-TAN 11.5MM X 42CM LEFT ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 71649742
Device Problem Activation, Positioning or SeparationProblem (2906)
Patient Problem Injury (2348)
Event Date 06/12/2020
Event Type  Injury  
Event Description
It was reported that a patient with a 1/3rd femur fracture was operated on (b)(6) 2020. Metatan nail (11. 5mm x 42cm) was inserted with 85mm/80mm lag/compression screws and 35mm & 40mm distal screws. During the insertion, whilst drilling with the starter drill for the compression screw, the tip of the starter drill broke off. The surgeon, with a little effort, managed to remove the broken off tip of the proximal lag screw. The screw/screwdriver seemed to be catching on something but the screw was inserted. No problem inserting the compression screw. Lateral post-op x-ray shows that the lag/compression screw combination has missed the nail. The patient was operated again (b)(6) 2020. The surgeon removed the misplaced lag/compression screws, attached the metatan jig without removing the distal screws or nail and reinserted new proximal screws (product code 71642680, batch no 19dt19274) without incident. The same instrument set was used (b)(6) 2020 as was used (b)(6) 2020.
 
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Brand NameMETA-TAN 11.5MM X 42CM LEFT
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis TN 38116
Manufacturer (Section G)
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis TN 38116
Manufacturer Contact
sarah freestone
1450 brooks road
memphis, TN 38116
0447940038
MDR Report Key10252411
MDR Text Key198163693
Report Number1020279-2020-03015
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeSF
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 08/25/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/09/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number71649742
Device Lot Number18JT09547
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/24/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 07/09/2020 Patient Sequence Number: 1
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