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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 Problem Connection Problem (2900)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/07/2021
Event Type  malfunction  
Event Description
It was reported that it was difficult for the surgeon to lock on a meta-nail anterior drop on june 7th during internal fixation surgery. No injury reported. It is unknown whether there was a surgical delay and how the surgery was completed.
 
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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
7000 west william cannon drive
austin, TX 78735
5123913905
MDR Report Key12042876
MDR Text Key257490801
Report Number1020279-2021-05312
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 company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/12/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/22/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number71654501
Device Catalogue Number71654501
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/11/2021
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

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