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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
Catalog Number 71674067
Device Problem Break (1069)
Patient Problem Not Applicable (3189)
Event Date 10/08/2018
Event Type  malfunction  
Event Description
It was reported that the surgeon states lag screw driver broken.Smith and nephew backup was used.No delay to procedure, no injury to patient.Device will be returned.
 
Manufacturer Narrative
It was reported that a lag screw driver broke during surgery.The associated device was not returned for evaluation.Thus the product analysis could not be performed.As batch details were not made available, the device history record review cannot be completed at this time.The lag screw driver is a reusable device that can be exposed to numerous surgeries; damage from repeated use can occur.Several potential factors that could contribute to the reported event, as reusable instruments are susceptible to damage from prolonged use and through misuse or rough handling.To avoid compromised performance or damage, it is recommended the device be inspected prior to/after each use and cleaning.It was reported that a smith and nephew backup was used and there was no delay to procedure and no injury to patient.A relationship, if any, between the device and the reported incident could not be corroborated at this time.Without the return of the actual product involved, our investigation of this report is inconclusive.No further investigation warranted for this complaint; and smith and nephew will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.
 
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Brand Name
LAG SCREW DRIVER
Type of Device
ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key8042097
MDR Text Key126272663
Report Number1020279-2018-02386
Device Sequence Number1
Product Code HSB
UDI-Device Identifier03596010560605
UDI-Public03596010560605
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,health
Type of Report Initial,Followup
Report Date 12/02/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/06/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number71674067
Was Device Available for Evaluation? No
Date Manufacturer Received11/25/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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