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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GUIDE PIN 3.2MM X 343MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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SMITH & NEPHEW, INC. GUIDE PIN 3.2MM X 343MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 71631436
Device Problem Material Twisted/Bent (2981)
Patient Problem Perforation (2001)
Event Date 05/31/2021
Event Type  Injury  
Event Description
It was reported that during trauma surgery, after inserting the guide pin 3. 2mm x 343mm for an intertan nail, the surgeon noticed that the guide pin was bent. The physician inserted another guide pin 3. 2mm x 343mm which also bent. There were extra pin holes in the femoral head as a result of the pins bending and the surgeon had to accommodate for the bending guide wires, the holes were not treated. A smith and nephew back up device was available. No delay reported. The patient's outcome is unknown. No further information is available.
 
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Brand NameGUIDE PIN 3.2MM X 343MM
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 Key12011307
MDR Text Key256700729
Report Number1020279-2021-05194
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 foreign,health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/01/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/16/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number71631436
Device Catalogue Number71631436
Device Lot Number21ASM0351
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/01/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/23/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/16/2021 Patient Sequence Number: 1
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