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

MAUDE Adverse Event Report: ARTHREX, INC. FIBULOCK IMPLANT SYSTEM, STERILE 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
 

ARTHREX, INC. FIBULOCK IMPLANT SYSTEM, STERILE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number FIBULOCK IMPLANT SYSTEM, STERILE
Device Problems Break (1069); Detachment of Device or Device Component (2907)
Patient Problems Tissue Damage (2104); Device Embedded In Tissue or Plaque (3165)
Event Date 08/15/2019
Event Type  Injury  
Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation. The device was reported to have been discarded. The root cause of the event could not be determined from the information available and without device evaluation.
 
Event Description
It was reported that during an ankle fx procedure, as the surgeon was inserting the guidewire that's included in the fibulock implant system, ar-8793ds, the gold tip broke off. The tip was unable to be retrieved from the patient as it was lodged within the bone canal. A fibulock nail was inserted inside of the same tunnel in which the tip broke off in, securing it within the bone.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameFIBULOCK IMPLANT SYSTEM, STERILE
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
ARTHREX, INC.
1370 creekside boulevard
naples FL 34108 1945
Manufacturer (Section G)
ARTHREX, INC.
1370 creekside boulevard
naples FL 34108 1945
Manufacturer Contact
vik bajnath
8009337001
MDR Report Key9289789
MDR Text Key184817349
Report Number1220246-2019-01400
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K173656
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date 11/07/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/07/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberFIBULOCK IMPLANT SYSTEM, STERILE
Device Catalogue NumberAR-8973DS
Device Lot Number10293742
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/16/2019
Was Device Evaluated by Manufacturer? No
Date Device Manufactured03/28/2019
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: 11/07/2019 Patient Sequence Number: 1
-
-