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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 130 RAD DRILL GDE DROP ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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SMITH & NEPHEW, INC. 130 RAD DRILL GDE DROP ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 71674003
Device Problem Loose or Intermittent Connection (1371)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/25/2021
Event Type  malfunction  
Manufacturer Narrative
Internal complaint reference number: (b)(4).
 
Event Description
It was reported that during surgery, the doctor hit the 130 rad drill gde drop attachment to the intertan guide with a mallet. This broke the mechanism to lock the intertan gold lag screw drill sleeve into place. The surgery was completed with the same device and no delays. All available information has been disclosed. If additional information should become available, a supplemental report will be submitted accordingly.
 
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Brand Name130 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
7000 west william cannon drive
austin, TX 78735
5123913905
MDR Report Key11540683
MDR Text Key241443700
Report Number1020279-2021-02262
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 company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/06/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/22/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number71674003
Device Catalogue Number71674003
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/26/2021
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 Unkown

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