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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. META-TAN LAG/COMP KIT 100/95 ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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SMITH & NEPHEW, INC. META-TAN LAG/COMP KIT 100/95 ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 71642600
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problem Failure of Implant (1924)
Event Date 06/17/2021
Event Type  Injury  
Event Description
It was reported that after an internal fixation surgery, performed on (b)(6) 2021, screws of meta-tan lag/comp kit 100/95 ((b)(4)) were used through an intertan 11. 5mm x 20cm 125d ((b)(4)), leading to early implant failure. With some further investigation, it was discovered that there was no sales rep present at the original operation, and the error was made by a junior clinician at point of surgery. The surgeon and hospital do not blame the implants at all, and the metatan screws have now been more clearly labelled for future reference. This issue was resolved with a revision performed on (b)(6) 2021.
 
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Brand NameMETA-TAN LAG/COMP KIT 100/95
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
holly topping
7000 west william cannon drive
austin, TX 78735
5123913905
MDR Report Key12105181
MDR Text Key259582818
Report Number1020279-2021-05620
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeAS
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 08/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/01/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number71642600
Device Catalogue Number71642600
Device Lot Number17HT90964
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 Received08/18/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured08/07/2017
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: 07/01/2021 Patient Sequence Number: 1
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