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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. EVOS 3.5MM X 75MM LCK SCR S-T PLATE, FIXATION, BONE

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SMITH & NEPHEW, INC. EVOS 3.5MM X 75MM LCK SCR S-T PLATE, FIXATION, BONE Back to Search Results
Model Number 72413575
Device Problem Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/18/2021
Event Type  malfunction  
Event Description
It was reported that during inspection, (3) evos 3. 5mm x 75mm lck scr s-t were found to be incorrectly packaged, because the screws on the package were 70cm screws and not 75cm screws. There was no patient involved.
 
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Brand NameEVOS 3.5MM X 75MM LCK SCR 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 Key12448533
MDR Text Key270623045
Report Number1020279-2021-06760
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K162078
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation
Remedial Action Recall
Type of Report Initial,Followup,Followup
Report Date 12/07/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/09/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number72413575
Device Catalogue Number72413575
Device Lot Number21FM24289
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received12/06/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/29/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberSEE H10

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