• 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. UNKN TRIGEN HUMERAL NAIL 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
 

SMITH & NEPHEW, INC. UNKN TRIGEN HUMERAL NAIL ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number UNKNOWN
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Bone Fracture(s) (1870)
Event Date 06/01/2018
Event Type  Injury  
Event Description
"it was reported that on literature review ""locking plate versus intramedullary nailing for proximal humeral fractures"", one patient suffered from a greater tuberosity displacement after undergoing a primary surgery with the trigen intramedullary nail system for a proximal humerus fracture. At 6 months postoperatively, it was obsered that the fracture had healed, that the intramedullary nail was in good position and that the large nodule bone was displaced upwards. It is unknown how the adverse event was treated. The patient returned to normal life and work. No further information is available.
 
Manufacturer Narrative
(b)(4). Doi: 10. 3977/j. Issn. 1005-8478. 2018. 12. 03.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameUNKN TRIGEN HUMERAL NAIL
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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 Key13656684
MDR Text Key286488412
Report Number1020279-2022-01002
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeCH
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Literature,Health Professional,User Facility,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 03/30/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/02/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/29/2022
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: 03/02/2022 Patient Sequence Number: 1
-
-