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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 42.5MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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SMITH & NEPHEW, INC. TRIGEN LOW PROFILE SCREW 5.0MM X 42.5MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 71645042
Device Problem Fracture (1260)
Patient Problems Failure of Implant (1924); Non-union Bone Fracture (2369); Unequal Limb Length (4534)
Event Date 07/05/2021
Event Type  Injury  
Event Description
It was reported that, after an open reduction with osteosynthesis had been performed on (b)(6) 2018 to treat an intertrochanteric femoral neck multifracture, the patient experienced pseudoarthrosis with a nonunion of the treated femoral fracture, a right leg length discrepancy, anteflexion deformity and the fracture of the intertan 11. 5mm x 38cm 125d rt along with the breakage of a proximal screw. A revision surgery was performed on (b)(6) 2021 to treat this adverse event. During this procedure, the nail and screws were removed, and a hip joint replacement construct was implanted. The patient¿s outcome is unknown.
 
Manufacturer Narrative
Internal complaint reference (b)(4).
 
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Brand NameTRIGEN LOW PROFILE SCREW 5.0MM X 42.5MM
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 Key13011240
MDR Text Key282279639
Report Number1020279-2021-08681
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K111025
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/03/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/15/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number71645042
Device Catalogue Number71645042
Device Lot Number15FT55116
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/10/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/20/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/30/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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