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

Catalog Number	72455307
Medical Device Problem Code	Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/26/2018
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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.

• Brand Name: EVOS PL-D FIBULA A/G PL 7H L 80MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7980226
• Report Number: 1020279-2018-02215
• Device Sequence Number: 1381048
• Product Code: HRS
• UDI-Device Identifier: 00885556641576
• UDI-Public: 00885556641576
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K170457
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 72455307
• Device Lot Number: 18EM18923
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/26/2018
• Supplement Date Received by Manufacturer: 09/26/2018
• Initial Report FDA Received Date: 10/18/2018
• Supplement Report FDA Received Date: 12/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1