Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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. HFN DRILL GUIDE; 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. HFN DRILL GUIDE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 71700005
Device Problems Difficult to Remove (1528); Connection Problem (2900)
Patient Problems No Consequences Or Impact To Patient (2199); Injury (2348)
Event Date 03/14/2019
Event Type  malfunction  
Event Description
It was reported that during surgery , the cylinder metal pegs from the radiolucent jig became wedged into the drill guide and required extreme force to dislodge breaking the guide in the process.Surgeon used the guides still following a few running repairs.Procedure was completed with the same device.Delay to the procedure was approximately 45 mins due to having to fix the drill guide and not having the ability of locking the proximal holes through the jig due to the radiolucent guide being loose.Used x-rays to make perfect circles.No injury or impact to patient.
 
Manufacturer Narrative
Adverse event or product problem,type of reportable event, labeled for single use.Correct information added.
 
Manufacturer Narrative
The associated complaint devices were not returned.Without the actual product involved and/or device information, our investigation cannot proceed.If the devices or new information is received in the future, the complaints can be re-opened.No further actions are being taken at this time.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
HFN DRILL GUIDE
Type of Device
ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key8482984
MDR Text Key140914409
Report Number1020279-2019-01378
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
PMA/PMN Number
K122170
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Type of Report Initial,Followup,Followup
Report Date 11/10/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/04/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number71700005
Date Manufacturer Received03/15/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
-
-