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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
Catalog Number 71674087
Device Problem Break (1069)
Patient Problems No Consequences Or Impact To Patient (2199); No Information (3190)
Event Date 09/08/2019
Event Type  malfunction  
Event Description
It was reported that during a procedure the rod broke while finishing to insert the lag screw. There was a delay reported of more than 2 hours. A s&n backup wasn't prepared prior the surgery, although it was delivered through the delay period. The device didn't break inside the patient, no fragments fell into the incision. The outcome of the patient was successful.
 
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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 road
memphis TN 38116
Manufacturer (Section G)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
Manufacturer Contact
sarah freestone
1450 brooks road
memphis, TN 38116
0447940038
MDR Report Key9163290
MDR Text Key161768777
Report Number1020279-2019-03568
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
PMA/PMN Number
K122170
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 11/12/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/07/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number71674087
Device Lot Number17HSP0002
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/06/2019
Was Device Evaluated by Manufacturer? No
Date Device Manufactured11/30/2017
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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