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U.S. Department of Health and Human Services

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

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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 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
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 Key13656591
MDR Text Key287343196
Report Number1020279-2022-01001
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? No
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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