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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 125 RAD DRILL GDE DROP ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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SMITH & NEPHEW, INC. 125 RAD DRILL GDE DROP ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 71674002
Device Problems Defective Device (2588); Connection Problem (2900)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/19/2020
Event Type  malfunction  
Event Description
While attending a short intertan nail for a neck of femur (nof) on a young female with stress fracture to inferior neck, it was found thickened cortices from long history of steroid use for immune disorder. A canal reaming was planned to accommodate 10mm 20cm nail. During the procedure, a short intertan nail was chosen, it was attached to drill guide (drill guide handle) and drop (125 rad drill gde drop) , the nail was introduced over ball tip guide wire. Proximal ics screw guide pin advanced using according drop, it was difficult to advance guide pin to 25mm tip apex (marked resistance). Lag drill (intertan lag screw drill) advanced over guide wire with much difficulty to the required depth (lag screw was tapped to get to the required depth). Black substance noted in flutes of drill. Then the compression drill (7. 0mm compression screw drill) met similar resistance but could get the required depth. A distal locking was attempted through the intertan drop, it marked resistance using the drill. A lateral x-ray confirmed screw was not in the nail but posterior to it, screw removed and no further attempt to distal lock was undertaken. A delay of less than 30 min was reported. Procedure concluded using the same devices. All available information has been disclosed. If additional information should become available, a supplemental report will be submitted accordingly.
 
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Brand Name125 RAD DRILL GDE 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 rd.
memphis, TN 38116
5123913905
MDR Report Key10689765
MDR Text Key211665307
Report Number1020279-2020-05475
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeAS
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,Followup
Report Date 05/19/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/16/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number71674002
Device Catalogue Number71674002
Device Lot Number16EM00844
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/28/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/18/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/02/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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