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

Model Number	72468104
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/22/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a procedure no locking screw was inserted in one of the distal locking holes.Once reduction was retained, the cortex screw was removed and a locking screw was inserted.The locking tabs, however, were too damaged and no screw could be placed in that hole.A delay of less than or equal to 30 minutes was reported.The procedure was completed with the same device.
Additional Manufacturer Narrative
H6, the device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, based on the information provided, we are unable to determine if adequate fixation was achieved without the placement of the distal screw.However, it was reported the procedure completed with the same device.According to the report, a delay of less than or equal to 30 minutes was reported.Since no harm has been alleged to this patient, no further clinical/medical assessment is warranted at this time.A review of complaint history did not reveal additional complaints for the listed device.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Possible causes could include but not limited to surgical technique used or user/procedural variance.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or 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 VOLAR PLATE 4H L STD 56MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10698100
• Report Number: 1020279-2020-05512
• Device Sequence Number: 16908820
• Product Code: HRS
• UDI-Device Identifier: 00885556672815
• UDI-Public: 00885556672815
• 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): 08/23/2021

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: 72468104
• Device Catalogue Number: 72468104
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/22/2020
• Supplement Date Received by Manufacturer: 08/20/2021
• Initial Report FDA Received Date: 10/19/2020
• Supplement Report FDA Received Date: 08/23/2021
• 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