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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. WIRE TENSIONER; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

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SMITH & NEPHEW, INC. WIRE TENSIONER; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT Back to Search Results
Model Number 71070341
Device Problem Defective Device (2588)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/27/2020
Event Type  Injury  
Event Description
It was reported that during surgery the wire tensioner was stuck in tensioner and can not get out.Wire tensioner would not release from wire.Wire was cut to release tensioner from wire.No delay.S&n back up device was available to complete the procedure.No injuries reported at this time.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
 
Manufacturer Narrative
The device, used in treatment, was returned for evaluation.A visual inspection of the returned device wire tensioner confirms the stated failure.The device has wire stuck on the inside of the tensioner and the tensioner will not release the wire.The wire tensioner is seized in place.This device was manufactured in 2018.This device exhibits signs of extensive wear/usage.A medical investigation will be performed.Proceed based on information provided/available for the investigation; if no relevant clinical information is provided, recommend closure.A review of complaint history on the listed part revealed no prior complaints for the listed batch with the same failure mode.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of risk management files found that the reported failure was documented appropriately.This device is a reusable instruments that can be exposed to numerous surgeries; damage from repeated use can occur.Expected wear/tear is likely the probable cause of the reported event.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, the need for corrective action is not indicated.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
WIRE TENSIONER
Type of Device
APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis TN 38116
MDR Report Key10569945
MDR Text Key208022858
Report Number1020279-2020-04791
Device Sequence Number1
Product Code KTT
UDI-Device Identifier08033201842072
UDI-Public08033201842072
Combination Product (y/n)N
PMA/PMN Number
K093047
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 10/29/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number71070341
Device Catalogue Number71070341
Device Lot Number18FP02028
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/11/2020
Initial Date Manufacturer Received 08/27/2020
Initial Date FDA Received09/22/2020
Supplement Dates Manufacturer Received10/15/2020
Supplement Dates FDA Received10/29/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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