• 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. 130 RAD DRILL GDE DROP 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. 130 RAD DRILL GDE DROP ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 71674003
Device Problems Naturally Worn (2988); Physical Resistance/Sticking (4012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/25/2021
Event Type  malfunction  
Event Description
It was reported that, during internal fixation surgery, a 130 rad drill gde drop was noticed to be worn and was not easily disengaged from a sleeve. No significant surgical delay was reported as the procedure was concluded using the same device. No patient injury was reported due to this event.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name130 RAD DRILL GDE DROP
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 Key11963553
MDR Text Key255043738
Report Number1020279-2021-05071
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 health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/16/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/08/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number71674003
Device Catalogue Number71674003
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/15/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

-
-