MAUDE Adverse Event Report: SMITH & NEPHEW, INC. EVOS 3.5 MM 1/3 TUBULAR PL 7H 82MM; PLATE, FIXATION, BONE

Model Number 72440807

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Loss of Range of Motion (2032); Malunion of Bone (4529)

Event Date 10/06/2020

Event Type  Injury  

Event Description

It was reported that, 12 month follow up after an internal fixation surgery had been performed, there was still non-union.The patient also reported limited functional impairment and extensive pain.No medical intervention was performed to address this adverse event.This information was collected from a post-market data collection activity.The data is anonymized; therefore, additional information is not known and it is not possible to collect it.

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, the data presented was from a post-market data collection activity.It was reported that, 12 months follow up after an internal fixation surgery had been performed, there was still non-union.The patient also reported limited functional impairment and extensive pain.No medical intervention was performed to address this adverse event.However, the information provided does not provide insight or relevance to current clinical outcomes for the product/device.Per subsequent e-mail, further information is not available.Without clinically relevant patient-specific supporting documentation, a thorough medical investigation cannot be performed.The root cause and/or patient outcome beyond that which was documented in the article cannot be confirmed nor concluded.In addition, the physician referenced in the abstract provided an analysis of all the attached images.Therefore, no further interpretation of the attached images is required.No further medical assessment is warranted at this time.A complaint history review found related failures for the listed device; this failure mode will be monitored for future complaints for any necessary corrective actions.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 are not limited to traumatic injury, material in use and/or post operative healing issue.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 3.5 MM 1/3 TUBULAR PL 7H 82MM
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 12329286
• MDR Text Key: 266840624
• Report Number: 1020279-2021-06396
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00885556646960
• UDI-Public: 00885556646960
• Combination Product (y/n): N
• PMA/PMN Number: K162078
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,study
• Type of Report: Initial,Followup
• Report Date: 09/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 72440807
• Device Catalogue Number: 72440807
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other