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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LAG SCREW DRIVER ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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SMITH & NEPHEW, INC. LAG SCREW DRIVER ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 71674087
Device Problem Physical Resistance/Sticking (4012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/17/2021
Event Type  malfunction  
Event Description
It was reported that, during a trauma surgery while the instruments were inside of the patient, the lag driver retaining rod assay capture stick caught onto a guide pin and seemed to be defective; the piece on the trigen t-handle was broken in the captures of the screwdriver. There were no pieces broken off inside of the patient. The procedure was successfully completed with no significant delay using a smith and nephew back up device. Patient was not harmed.
 
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Brand NameLAG SCREW DRIVER
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 Key11909918
MDR Text Key253533018
Report Number1020279-2021-04873
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,Followup
Report Date 08/04/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/31/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number71674087
Device Catalogue Number71674067
Device Lot Number08LCT0019
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/03/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/30/2008
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 05/31/2021 Patient Sequence Number: 1
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