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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. CANNULATED IMPACTOR- MED ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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SMITH & NEPHEW, INC. CANNULATED IMPACTOR- MED ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 71675081
Device Problems Difficult to Remove (1528); Mechanical Jam (2983)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/16/2021
Event Type  malfunction  
Event Description
It was reported that, during surgery, was found a cross threading of the impactor in the drill guide handle. And while trying to remove impactor screw bussing came away from drill guide handle and remained stuck on impactor. Instruments were outside the patient. There was no delay and procedure was completed with the same device.
 
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Brand NameCANNULATED IMPACTOR- MED
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 Key11646921
MDR Text Key244851376
Report Number1020279-2021-02882
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K122170
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/08/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/11/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number71675081
Device Catalogue Number71675081
Device Lot NumberUNKNOWN
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 Received06/07/2021
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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