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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TRIGEN LOW PROFILE SCREW 5.0MM X 50MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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SMITH & NEPHEW, INC. TRIGEN LOW PROFILE SCREW 5.0MM X 50MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 71645050
Device Problem Break (1069)
Patient Problems Failure of Implant (1924); Pain (1994); Discomfort (2330); Deformity/ Disfigurement (2360); Non-union Bone Fracture (2369); Unequal Limb Length (4534)
Event Date 02/23/2022
Event Type  Injury  
Event Description
It was reported that, a trauma surgery was performed on the (b)(6)2021 to treat a broken femur and a meta-tan 11. 5mm x 44cm right was implanted. Months later, the bottom screws broke, as well as the nail itself and the implant was unstable with a significant varus deformity of the proximal femur. The patient underwent a complex revision surgery on the(b)(6)2022 to treat this adverse event, when the patient had an orif system implanted. The patient is recovering.
 
Manufacturer Narrative
Internal reference number: (b)(4).
 
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Brand NameTRIGEN LOW PROFILE SCREW 5.0MM X 50MM
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 Key14022767
MDR Text Key288681136
Report Number1020279-2022-01551
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K111025
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 05/09/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/06/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number71645050
Device Catalogue Number71645050
Device Lot Number19BT16234
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received05/05/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/05/2019
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: 04/06/2022 Patient Sequence Number: 1
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