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

Model Number	72468204
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during an unknown trauma procedure, as the screw was being screwed into the bone, it went thorough the plate.Procedure finished with a competitor device.Surgical delay less than or equal to 30 minutes.The patient outcome is unknown.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history did not reveal additional complaints for the listed batch.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.Some potential probable causes for this event could include but not limited to procedural/user error, surgical complication or 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.

• Brand Name: EVOS VOLAR PLATE 4H R STD 56MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10817519
• Report Number: 1020279-2020-06348
• Device Sequence Number: 1872280
• Product Code: HRS
• UDI-Device Identifier: 00885556672846
• UDI-Public: 00885556672846
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/17/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 72468204
• Device Catalogue Number: 72468204
• Device Lot Number: 20FT38406
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/25/2020
• Supplement Date Received by Manufacturer: 08/16/2021
• Initial Report FDA Received Date: 11/10/2020
• Supplement Report FDA Received Date: 08/17/2021
• 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: Other; Required Intervention