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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TAN/FAN PERC DRILL GUIDE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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SMITH & NEPHEW, INC. TAN/FAN PERC DRILL GUIDE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 71631021
Device Problem Failure to Align (2522)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/12/2021
Event Type  malfunction  
Event Description
It was reported that, during a trigen tan surgery, the doctor faced several issues with its instruments. Also, there was mismatch/alignment between hole and drill bit. Surgery was resumed, with a greater than 30 minutes delay, with a competitor device. Patient was not harmed as consequence of this problem.
 
Manufacturer Narrative
Internal complaint reference (b)(4).
 
Manufacturer Narrative
Internal complaint reference (b)(4).
 
Event Description
It was reported that, during a trigen tan surgery, the doctor faced several issues with its instruments. Also, there was mismatch/alignment between hole and drill bit. Surgery was resumed, with a greater than 30 minutes delay, with a competitor device. Patient was not harmed as consequence of this problem.
 
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Brand NameTAN/FAN PERC DRILL GUIDE
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 Key13113696
MDR Text Key285327935
Report Number1020279-2021-08964
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
K122170
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/22/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/29/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number71631021
Device Catalogue Number71631021
Device Lot Number17GSP0004
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/18/2022
Was Device Evaluated by Manufacturer? No
Date Device Manufactured11/08/2017
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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