• 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. 4.0MM F-T CAC SCRW 45MM PLATE, FIXATION, BONE

  • 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. 4.0MM F-T CAC SCRW 45MM PLATE, FIXATION, BONE Back to Search Results
Model Number 71805245
Device Problem Material Fragmentation (1261)
Patient Problem Foreign Body In Patient (2687)
Event Date 06/17/2020
Event Type  Injury  
Event Description
It was reported that the surgeon was hand tightening a periloc 4. 0 x 45mm fully threaded cancellous screw in to the patient's tibia when the head of the screw broke. The broken part fell inside the patient and could not be retrieved successfully. A delay of 0 to 30 minutes reported. An s&n backup was available. No additional patient injuries reported, other than the broken piece remaining inside.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name4.0MM F-T CAC SCRW 45MM
Type of DevicePLATE, FIXATION, BONE
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 Key10280698
MDR Text Key199044640
Report Number1020279-2020-03249
Device Sequence Number1
Product Code HRS
UDI-Device Identifier03596010521729
UDI-Public03596010521729
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K033669
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 06/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/15/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number71805245
Device Catalogue Number71805245
Device Lot NumberUNKNOWN
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 Received06/17/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 07/15/2020 Patient Sequence Number: 1
-
-