• 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 SCREW, 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
 

WRIGHTS LANE SYNTHES USA PRODUCTS LLC SCREW, FIXATION, BONE Back to Search Results
Device Problem Unintended Movement (3026)
Patient Problem Failure of Implant (1924)
Event Type  Injury  
Manufacturer Narrative

Patient information not available for reporting. Date of event: date of device migration is not known. This report is for an unknown lag screw/unknown lot. Part and lot numbers are unknown; udi number is unknown. Implanted date: date of implant is not known. Complainant part is not expected to be returned for manufacturer review/investigation. Without a lot number the device history records review could not be completed. The investigation could not be completed; no conclusion could be drawn, as no product was received. 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 a patient underwent revision of an advanced proximal femoral nailing system (tfna) on (b)(6) 2018 due to cut out of the lag screw. The hardware was removed intact. Patient was revised to a total hip replacement. Initial surgery date is unknown. Surgery was completed successfully with no delays and no additional x-rays. Patient outcome was satisfactory. This report is for one (1) unknown tfna lag screw. This is report 1 of 1 for (b)(4).

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Type of DeviceSCREW, FIXATION, BONE
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
Manufacturer Contact
michael cote
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key7287238
MDR Text Key100647013
Report Number2939274-2018-50712
Device Sequence Number1
Product Code HWC
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial
Report Date 01/26/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/21/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
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 Received01/26/2018
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 02/21/2018 Patient Sequence Number: 1
-
-