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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. META ANTERIOR DROP ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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SMITH & NEPHEW, INC. META ANTERIOR DROP ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 71654501
Device Problems Failure to Align (2522); Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/30/2021
Event Type  malfunction  
Event Description
It was reported that during knee surgery two meta anterior drops were deformed and not targeting the nail adequately. A delay of less than or equal to 30mins was reported. No injury reported. It is unknown how the procedure was finished and when occurred.
 
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Brand NameMETA ANTERIOR DROP
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
1450 brooks road
memphis, TN 38116
5123913905
MDR Report Key11711037
MDR Text Key248154286
Report Number1020279-2021-03319
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K122170
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 06/14/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/22/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number71654501
Device Catalogue Number71654501
Device Lot Number06JSP0003
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/09/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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