MAUDE Adverse Event Report: SMITH & NEPHEW, INC. EVOS 2.7/3.5 OLCRNN PL W/TNS 4H L 82MM; PLATE, FIXATION, BONE

Model Number	72466304
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/05/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the evos 2.7mm/3.5mm olecranon plate with tines 4h l 82mm was implanted in the right arm of the patient and later it was found out that the device was intended for the left side.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
Date of event: information was updated.
Event or Problem Description
It was reported that the evos 2.7mm/3.5mm olecranon plate with tines 4h l 82mm was implanted in the right arm of the patient and later it was found out that the device was intended for the left side.The patient is in good health and has not experienced any problems.The labeling of the device was not incorrect.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, although the procedure was performed on the incorrect side per report ¿the labeling of the device was not incorrect¿ and ¿the patient is in good health and has not experienced any problems.¿ the future impact to the patient beyond the procedure cannot be determined.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 probable cause could include but not limited to procedural variance or user error.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 2.7/3.5 OLCRNN PL W/TNS 4H L 82MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10203465
• Report Number: 1020279-2020-02790
• Device Sequence Number: 16398847
• Product Code: HRS
• UDI-Device Identifier: 00885556665046
• UDI-Public: 00885556665046
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K173293
• 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,Followup
• Report Date (Section B): 08/20/2021

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: 72466304
• Device Catalogue Number: 72466304
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/05/2020
• Supplement Date Received by Manufacturer: 07/01/2020; 08/19/2021
• Initial Report FDA Received Date: 06/26/2020
• Supplement Report FDA Received Date: 07/01/2020; 08/20/2021
• 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: Required Intervention