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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. EVOS 2.0MM X 12MM LCK SCR T6 S-T PLATE, FIXATION, BONE

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SMITH & NEPHEW, INC. EVOS 2.0MM X 12MM LCK SCR T6 S-T PLATE, FIXATION, BONE Back to Search Results
Model Number 72412012N
Device Problem Fracture (1260)
Patient Problems Failure of Implant (1924); Unspecified Infection (1930)
Event Date 06/03/2022
Event Type  Injury  
Manufacturer Narrative
Internal complaint reference: case-(b)(4).
 
Event Description
It was reported that after a wrist surgery performed on (b)(6) 2022 one of the evos 2. 0mm x 12mm lck scr t6 s-t broke with just hand twisting. A revision surgery was performed on (b)(6) 2022 to solve the issue. Further information is unknown at the moment.
 
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Brand NameEVOS 2.0MM X 12MM LCK SCR T6 S-T
Type of DevicePLATE, FIXATION, BONE
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 Key14843049
MDR Text Key294872190
Report Number1020279-2022-03136
Device Sequence Number1
Product Code HRS
UDI-Device Identifier00885556443644
UDI-Public00885556443644
Combination Product (y/n)N
Reporter Country CodeMY
PMA/PMN Number
K140814
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/20/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/28/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number72412012N
Device Catalogue Number72412012N
Device Lot Number21DM11079
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received09/16/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured04/16/2021
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: 06/28/2022 Patient Sequence Number: 1
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