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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. EVOS 2.7MM L-D FIBULA PL 11H R 103MM; NAIL, FIXATION, BONE
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SMITH & NEPHEW, INC. EVOS 2.7MM L-D FIBULA PL 11H R 103MM; NAIL, FIXATION, BONE Back to Search Results
Device Problem Connection Problem (2900)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/17/2020
Event Type  malfunction  
Event Description
It was reported that during surgery, locking screws (2.7mm) did not fully seat within the plate as they should have.Final tightening was done on hand and when the threads were engaging they locked up and made a squeaking sound before they fully sat.The screws were removed and replaced with other smith nephew 2.7 screws and the surgery finished successfully.No delay and no injury reported.
 
Manufacturer Narrative
The devices, used in treatment were not returned for evaluation, reporting event could not be confirmed.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.Some potential probable causes for this event could include a fit/ sizing issue or poor insertion technique.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.Without the actual product involved and/or device information, our investigation cannot proceed.
 
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Brand Name
EVOS 2.7MM L-D FIBULA PL 11H R 103MM
Type of Device
NAIL, FIXATION, BONE
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key9659521
MDR Text Key177399429
Report Number1020279-2020-00454
Device Sequence Number1
Product Code JDS
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 03/25/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/03/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Date Manufacturer Received03/18/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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