MAUDE Adverse Event Report: SMITH & NEPHEW, INC. EVOS 2.7/3.5MM PL-D HUM PL 17H R 206MM; PLATE, FIXATION, BONE

Model Number	72466217
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/05/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during procedure and inside the patient the two evos posterolateral distal humerus screws holes failed to engage with the locking screws.S+n backup device available.Surgery was delayed for no more than 30 min.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation but the pictures were reviewed, and the failure to engage the screws was confirmed.The clinical/medical investigation concluded that, undated, unlabeled x-ray was reviewed, however, it does not provide a root cause of the reported event.Without supporting clinical documentation or the s&n device, the root cause of the reported failure cannot be concluded.Although, we cannot rule out a procedural variance as a contributing factor.Based on the information provided, the surgery completed using a 4.0 osteopenia screw instead, which resolved the problem with a less than or equal to 30-minute delay.Since the reported issue was resolved, no further clinical/medical assessment is warranted at this time.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 a fit/ sizing issue or poor insertion technique.Based on this investigation, the need for corrective action is not indicated.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 2.7/3.5MM PL-D HUM PL 17H R 206MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10480550
• Report Number: 1020279-2020-04364
• Device Sequence Number: 2628335
• Product Code: HRS
• UDI-Device Identifier: 00885556664919
• UDI-Public: 00885556664919
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K173293
• 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): 09/23/2021

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: 72466217
• Device Catalogue Number: 72466217
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/05/2020
• Supplement Date Received by Manufacturer: 09/22/2021
• Initial Report FDA Received Date: 09/01/2020
• Supplement Report FDA Received Date: 09/23/2021
• 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