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U.S. Department of Health and Human Services

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

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SMITH & NEPHEW, INC. LAG DRIVER RETAINING ROD ASSY ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 71674087
Device Problem Material Separation (1562)
Patient Problem Foreign Body In Patient (2687)
Event Date 07/01/2020
Event Type  Injury  
Event Description
It was reported that, during trauma surgery, while removing the lag driver retaining rod assembly from lag screw after seating the screw, the surgeon pulled the lag driver retaining rod assy. The lag driver retaining rod assembly was still connected to the lag screw, and then the tip of the lag driver retaining rod assembly broke inside the patient's body. The piece was not removed and remains inside the patient. There is no plan to remove the tip from patient at this moment. The procedure was finished with no surgical delay.
 
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Brand NameLAG DRIVER RETAINING ROD ASSY
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
sarah freestone
1450 brooks rd.
memphis, TN 38116
0447940038
MDR Report Key10292502
MDR Text Key199439727
Report Number1020279-2020-03310
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K122170
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/29/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/17/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number71674087
Device Catalogue Number71674087
Device Lot Number11FSP0011
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 Received07/01/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 07/17/2020 Patient Sequence Number: 1
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