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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN TRIGEN HUMERAL NAIL SCREW ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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SMITH & NEPHEW, INC. UNKN TRIGEN HUMERAL NAIL SCREW ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number UNKNOWN
Device Problem Migration (4003)
Patient Problems Bone Fracture(s) (1870); Failure of Implant (1924); Post Operative Wound Infection (2446)
Event Date 06/01/2018
Event Type  Injury  
Manufacturer Narrative
Internal complaint reference: (b)(4). Doi: 10. 3977/j. Issn. 1005-8478. 2018. 12. 03.
 
Event Description
It was reported that on literature review "locking plate versus intramedullary nailing for proximal humeral fractures", 11 patients had a complication after being treated with the trigen intramedullary nail system for a proximal humerus fracture. 5 patients suffered from a superficial incision infection, that were treated with dressing changes and antibiotic treatment. These patients healed successfully after treatment. 3 patients suffered from a screw cut out and it is unknown how these adverse events were treated. 3 patients suffered from a greater tuberosity displacement and it is also unknown how these adverse events were treated. All patients returned no normal work and life. No further information is available.
 
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Brand NameUNKN TRIGEN HUMERAL NAIL SCREW
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 Key13656642
MDR Text Key286531020
Report Number1020279-2022-01000
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 04/04/2022
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 Received04/01/2022
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
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