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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN TRIGEN META-TAN TROCH ANTEGR NAIL IMPL ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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SMITH & NEPHEW, INC. UNKN TRIGEN META-TAN TROCH ANTEGR NAIL IMPL ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number UNKNOWN
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Insufficient Information (4580)
Event Date 05/03/2020
Event Type  Injury  
Event Description
It was reported that on literature review "suprapatellar nailing in proximal third tibial fractures - clinicoradiological outcome", 6 patients underwent implant removal due to unknown reasons. No further information is available.
 
Manufacturer Narrative
Internal complaint reference: (b)(4). Kulkarni, m. S. , tummala, m. , aroor, m. N. , vijayan, s. , & rao, s. K. (2020). Suprapatellar nailing in proximal third tibial fractures-clinicoradiological outcome. Injury, 51(8), 1879-1886. Doi: 10. 1016/j. Injury. 2020. 05. 008.
 
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Brand NameUNKN TRIGEN META-TAN TROCH ANTEGR NAIL IMPL
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 Key14252151
MDR Text Key290400338
Report Number1020279-2022-02058
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeIN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Literature,Health Professional,User Facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/23/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/29/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/20/2022
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: 04/29/2022 Patient Sequence Number: 1
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