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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. EVOS 2.4MM X 10MM CTX SCR T7 S-T PLATE, FIXATION, BONE

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SMITH & NEPHEW, INC. EVOS 2.4MM X 10MM CTX SCR T7 S-T PLATE, FIXATION, BONE Back to Search Results
Model Number 72402410
Device Problems Material Fragmentation (1261); Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/23/2022
Event Type  malfunction  
Event Description
It was reported that evos 2. 4mm x 10mm ctx scr t7 s-t has visible steel debris, probably due to production and/or ruined thread. No case was involved; therefore, there was no patient involvement.
 
Manufacturer Narrative
Internal complaint reference: case-(b)(4).
 
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Brand NameEVOS 2.4MM X 10MM CTX SCR T7 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 Key14655092
MDR Text Key294873960
Report Number1020279-2022-02876
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeNO
PMA/PMN Number
K140814
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/30/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/10/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number72402410
Device Catalogue Number72402410
Device Lot Number21LM01843
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/07/2022
Is the Reporter a Health Professional? No
Date Manufacturer Received08/12/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/02/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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