• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. META-TAN LAG SCREW DRIVER ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SMITH & NEPHEW, INC. META-TAN LAG SCREW DRIVER ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 71631440
Device Problem Defective Component (2292)
Patient Problem Injury (2348)
Event Date 10/21/2019
Event Type  malfunction  
Event Description
It was reported that during surgery the end of retraining rod was damaged. Surgeon cut his hand on the device. The procedure was finished with a different instrument. No delay reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameMETA-TAN LAG SCREW DRIVER
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
0447940038
MDR Report Key9282346
MDR Text Key165308241
Report Number1020279-2019-03906
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K122170
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 02/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/05/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number71631440
Device Lot Number15FSY0022
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/30/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/11/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/27/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 11/05/2019 Patient Sequence Number: 1
-
-