• 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 RFNA / 11 / 400 5 DEG BEND / 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
 

WRIGHTS LANE SYNTHES USA PRODUCTS LLC RFNA / 11 / 400 5 DEG BEND / STERILE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 04.233.140S
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Wound Dehiscence (1154); Pulmonary Embolism (1498); Hematoma (1884); Unspecified Infection (1930)
Event Date 03/16/2022
Event Type  Injury  
Manufacturer Narrative
This report is 1 of 7 for (b)(4). Complainant part is not expected to be returned for manufacturer review/investigation. The investigation could not be completed; no conclusion could be drawn, as no product was received. 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. 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) 2022, the patient came to operating room for removal of rfna due to infection. The surgeon voiced that after nail was originally inserted patient had received heparin for a significant pe and developed a large hematoma at surgical site which ultimately lead to the wound breaking down. He believes this is what lead to the patient having an infection. Rfna was explanted and antibiotic spacer was placed.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameRFNA / 11 / 400 5 DEG BEND / STERILE
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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
kate karberg
1302 wright lane east
west chester, PA 19380
3035526892
MDR Report Key14111402
MDR Text Key289261931
Report Number2939274-2022-01296
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K201346
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/14/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number04.233.140S
Device Catalogue Number04.233.140S
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/16/2022
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: 04/14/2022 Patient Sequence Number: 1
Treatment
UNK - SCREWS: 5.0 MM LOCKING; UNK - SCREWS: 5.0 MM LOCKING; UNK - SCREWS: 5.0 MM LOCKING; UNK - SCREWS: 5.0 MM LOCKING; UNK - SCREWS: 5.0 MM LOCKING; UNK - SCREWS: 5.0 MM LOCKING
-
-