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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. EVOS PL-D FIBULA A/G PL 7H L 80MM PLATE, FIXATION, BONE

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SMITH & NEPHEW, INC. EVOS PL-D FIBULA A/G PL 7H L 80MM PLATE, FIXATION, BONE Back to Search Results
Catalog Number 72455307
Device Problem Device Damaged by Another Device (2915)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/26/2018
Event Type  malfunction  
Event Description
It was reported that a malfunction has occurred. When dr. Was inserting a 3. 5mm cortex screw into the plate by hand the star tabs broke and the screw went through the plate. The doctor took the screw that went through the plate out and did not place a screw back into the damaged hole. Dr. Kept the plate in and inserted a few more screws throughout the plate.
 
Manufacturer Narrative
The associated screw was returned and evaluated. The associated plate was not returned for evaluation. A visual assessment of the screw could not confirm the stated failure mode. The screw did show significant wear/damage in the hex region. The assessment of the surgical images provided by the customer did confirm the stated failure mode. A whole in the plate did not have tabs suggesting a screw did pass through the whole and therefore did not function as intended. The clinical medical investigation concluded that no further assessment was warranted at this time. Based on reported clinical information provided in addition to the product evaluation, the root cause of the broken component was a user/procedural event. The future impact to the patient cannot be determined. A review of complaint history did not reveal additional complaints for the listed plate batch. A review of the manufacturing records for the plate did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident. 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 is 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 NameEVOS PL-D FIBULA A/G PL 7H L 80MM
Type of DevicePLATE, FIXATION, BONE
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key7980226
MDR Text Key124175893
Report Number1020279-2018-02215
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
PMA/PMN Number
K170457
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 12/11/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/18/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number72455307
Device Lot Number18EM18923
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/26/2018
Is This a Reprocessed and Reused Single-Use Device? No

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