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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 25MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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SMITH & NEPHEW, INC. TRIGEN LOW PROFILE SCREW 5.0MM X 25MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 71645025
Device Problems Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bacterial Infection (1735); Impaired Healing (2378)
Event Date 04/07/2021
Event Type  Injury  
Event Description
It was reported that, due to a fall on (b)(6) 2020, a patient experienced a right tibial fracture which required a temporary treatment with an external fixator on (b)(6) 2020. This external fixator was removed on (b)(6) 2020 and after a right tibial internal infixation surgery with trigen low profile screw 5. 0mm x 35mm performed the same day, the patient experienced loosening of distal screws, secretion and wound healing problems with the presence of staphylococcus aureus in the area of distal locking. X-ray scans showed that there was a proximal locking screw perforated which later on during revision surgery was noticed broken. A revision surgery was performed on (b)(6) 2021 to treat this adverse event. The trigen low profile screw 5. 0mm x 35mm ((b)(4)), low profile screw 5. 0mm x 35mm ((b)(4)), int hex cap scr 5. 0mm x 35mm ((b)(4)), trigen low profile screw 5. 0mm x 40mm ((b)(4)), trigen low profile screw 5. 0mm x 55mm ((b)(4)) and trigen low profile screw 5. 0mm x 25mm ((b)(4)) alongside with the nail meta-nail tibial 10mm x 36cm were explanted during this revision surgery. Despite of the tibial fracture being diagnosed as "somewhat submerged and shortened", the surgeon advised that the healing process of the incompletely consolidated fracture can be awaited, but there is a risk of pseudoarthrosis formation. For this, an additional surgery will be discussed and evaluated with the patient to implant a larger intramedullary nail or a plate system, both possible once the infectious situation has been completely rehabilitated. Patient outcome is post-op with antibiotic regime.
 
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Brand NameTRIGEN LOW PROFILE SCREW 5.0MM X 25MM
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis TN 38116
MDR Report Key12046396
MDR Text Key257693267
Report Number1020279-2021-05350
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
PMA/PMN Number
K111025
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup
Report Date 10/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/22/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number71645025
Device Catalogue Number71645025
Device Lot Number16HT74801
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/26/2021
Was Device Evaluated by Manufacturer? No Answer Provided
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: 06/22/2021 Patient Sequence Number: 1
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