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. FLEXIBLE DRILL 35MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
  • 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. FLEXIBLE DRILL 35MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED Back to Search Results
Model Number 71362935
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/05/2019
Event Type  malfunction  
Event Description
It was reported that during surgery, the 35mm drill bit was being used to drill through the r3 cup to place a screw into the cup when it broke into multiple pieces.It is unknown if there were any delays or a backup device available in the procedure.
 
Event Description
It was reported that during surgery, the 35mm drill bit was being used to drill through the r3 cup to place a screw into the cup when it broke into multiple pieces inside the patient.All the pieces were recovered.There was an s&n backup available.There were no delays in the procedure and no patient injuries were reported.
 
Manufacturer Narrative
Event description (b5) was updated.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
FLEXIBLE DRILL 35MM
Type of Device
PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key9533553
MDR Text Key177212031
Report Number1020279-2019-04705
Device Sequence Number1
Product Code JDI
UDI-Device Identifier03596010464668
UDI-Public03596010464668
Combination Product (y/n)N
PMA/PMN Number
K123598
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 01/06/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number71362935
Device Catalogue Number71362935
Initial Date Manufacturer Received 12/05/2019
Initial Date FDA Received12/30/2019
Supplement Dates Manufacturer Received01/07/2020
01/05/2021
Supplement Dates FDA Received01/24/2020
01/06/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-