MAUDE Adverse Event Report: SMITH & NEPHEW, INC. EVOS VOLAR PLATE 4H R STD 56MM; PLATE, FIXATION, BONE

Model Number	72468204
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	Injury (2348)
Date of Event	04/03/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the locking screw passed through the plate hole completely.In order to remove the locking screw, the entire plate was removed.The surgeon used the old style peri-loc vdr system to complete the case to his proper standards.
Additional Manufacturer Narrative
The associated devices, used in treatment, were returned and evaluated.A visual inspection of the returned devices confirmed the stated failure mode.The locking holes were damaged on the plate from the attempted implantation.The heads on the screws were damaged from use.The plate was manufactured in 2019.All screws were inspected and met specification.A dimensional inspection was attempted on the plate but it was too damaged from use to obtain accurate measurements.The medical investigation concluded that, during the use of the evos volar plate, the locking screw passed through the plate hole completely and in order to remove the locking screw, the entire plate was removed.The visual inspection revealed the locking holes and heads of the screws were damaged from the attempted implantation.In order to complete the procedure the surgeon used the old style peri-loc vdr system.No patient injuries or delays are being reported.Since no harm to the patient is being reported and a backup device was available no further medical assessment is warranted.A complaint history review found related failures; this failure mode will be monitored for future complaints and assessed for any necessary corrective actions.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.The potential probable cause for this event is likely an improper surgical technique.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaints will be reopened.No further investigation is warranted for these complaints; however, we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: EVOS VOLAR PLATE 4H R STD 56MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8547389
• Report Number: 1020279-2019-01676
• Device Sequence Number: 16221681
• Product Code: HRS
• UDI-Device Identifier: 00885556672846
• UDI-Public: 00885556672846
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K181533
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2020

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?: No
• Operator of Device: Health Professional
• Device Model Number: 72468204
• Device Catalogue Number: 72468204
• Device Lot Number: 19AT14579
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2019
• Initial Date Received by Manufacturer: 04/03/2019
• Supplement Date Received by Manufacturer: 04/03/2019
• Initial Report FDA Received Date: 04/24/2019
• Supplement Report FDA Received Date: 03/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention