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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DRILL GUIDE HANDLE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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SMITH & NEPHEW, INC. DRILL GUIDE HANDLE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 71674001
Device Problems Naturally Worn (2988); Incomplete or Inadequate Connection (4037)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/18/2021
Event Type  malfunction  
Event Description
It was reported that, during trauma surgery, a trigen drill guide handle was noticed to be worn out and broken. This was observed outside the patient. Surgery was resumed, without any delay, with the same device. Patient was not harmed as consequence of this problem.
 
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Brand NameDRILL GUIDE HANDLE
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 Key12112116
MDR Text Key260481186
Report Number1020279-2021-05647
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 health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/20/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/02/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number71674001
Device Catalogue Number71674001
Device Lot Number08HGT0030
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/19/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/31/2008
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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