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

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TFNA SCREW 85MM - STERILE ROD, FIXATION, INTRAMEDULLARY

  • 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
 

WRIGHTS LANE SYNTHES USA PRODUCTS LLC TFNA SCREW 85MM - STERILE ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Model Number 04.038.085S
Device Problem Break (1069)
Patient Problems Calcium Deposits/Calcification (1758); Pain (1994); Impaired Healing (2378); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation. Reporter is a synthes legal professional. Without a lot number the device history records review could not be completed. Product was not returned. Based on the information available, it has been determined that no corrective and/or preventative action is proposed. This complaint will be accounted for and monitored via post market surveillance activities. If additional information is made available, the investigation will be updated as applicable. (b)(4). Device was used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
It was reported that on (b)(6) 2019, the patient underwent removal of an intramedullary nail and screw fixator because of increasing pain with feelings of leg shortening as well as a broken left intertrochanteric femoral nail. The portion of the trochanteric fixation nail (tfna) was removed as well as the proximal screw. The distal screw was backed up to allow for passing of the extraction hook once this has been passed to. The nail was removed and then the distal portion of the nail was removed without issue. Once this had been accomplished and arthrotomy was made as well as removal of heterotropic ossification around the greater trochanter to facilitate removal of the next segment once the neck segment had been removed. Another stem was implanted in the patient. On or about (b)(6) 2018, the patient underwent intramedullary nail fixation of the left intertrochanteric femur fracture with closed reduction and casting of left distal radius fracture. Patient presented with a left intertrochanteric femur fracture with left multisegmental distal radius fracture. This report is for a tfna screw 85mm - sterile. This is report 2 of 2 for (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameTFNA SCREW 85MM - STERILE
Type of DeviceROD, FIXATION, INTRAMEDULLARY
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
Manufacturer (Section G)
MONUMENT
1101 synthes avenue
monument CO 80132
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key8928230
MDR Text Key156289346
Report Number2939274-2019-60078
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K131548
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,other
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 07/26/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/23/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number04.038.085S
Device Catalogue Number04.038.085S
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/10/2019
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?
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 08/23/2019 Patient Sequence Number: 1
-
-