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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. RULER; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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SMITH & NEPHEW, INC. RULER; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 71674079
Device Problem Break (1069)
Patient Problem No Patient Involvement (2645)
Event Date 05/27/2020
Event Type  malfunction  
Event Description
It was reported that the tip of the device was found broken.No case involved.
 
Manufacturer Narrative
The device, intended use in treatment, was returned for evaluation.A visual inspection of the returned ruler sleeve confirms the threads are broken off the device.The threads are broken off in the nut.This device show signs of significant wear/usage.The device was manufactured in 2016.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.The device is a reusable instrument that can be exposed to numerous surgeries and cleaning cycles.As plastics are vulnerable and crack may have initiated during use and possible causes could be due to the heating and cooling associated with autoclaving or prolonged use.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, corrective and preventive action is indicated to mitigate future recurrence of similar events.Should additional information be received, the complaint will be reopened.No further investigation warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.
 
Manufacturer Narrative
The device, intended use in treatment, was returned for evaluation.A visual inspection of the returned ruler sleeve confirms the threads are broken off the device.The threads are broken off in the nut.This device show signs of significant wear/usage.The device was manufactured in 2016.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.The device is a reusable instrument that can be exposed to numerous surgeries and cleaning cycles.As plastics are vulnerable and crack may have initiated during use and possible causes could be due to the heating and cooling associated with autoclaving or prolonged use.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, corrective and preventive action is indicated to mitigate future recurrence of similar events.Should additional information be received, the complaint will be reopened.No further investigation warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.
 
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Brand Name
RULER
Type of Device
ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis TN 38116
MDR Report Key10177324
MDR Text Key195931348
Report Number1020279-2020-02635
Device Sequence Number1
Product Code HSB
UDI-Device Identifier03596010560759
UDI-Public03596010560759
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,Followup
Report Date 09/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/21/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number71674079
Device Catalogue Number71674079
Device Lot Number16ACT0009
Date Manufacturer Received08/20/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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