MAUDE Adverse Event Report: SMITH & NEPHEW, INC. EVOS 3.5MM 1/3 TUBULAR PL 8H 94MM; SCREW, FIXATION, BONE

Model Number	72440808
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032)
Date of Event	10/06/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after 12 month follow up after an internal fixation surgery had been performed, the patient was added to the waiting list for revision surgery due to decreased rom and pain.Primary fracture fixation surgery was performed due to a fibula fracture and the union/correction process was achieved in 12 months.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.
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, the data presented was from a post-market data collection activity.It was reported that, after 12 months follow up after an internal fixation surgery had been performed, the patient was added to the waiting list for revision surgery due to decreased rom and pain.Primary fracture fixation surgery was performed due to a fibula fracture and the union/correction process was achieved in 12 months.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.Some potential probable causes could be alignment, fit/size of device used or wear.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 3.5MM 1/3 TUBULAR PL 8H 94MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 12329295
• Report Number: 1020279-2021-06399
• Device Sequence Number: 11446458
• Product Code: HWC
• UDI-Device Identifier: 00885556640043
• UDI-Public: 00885556640043
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K162078
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,study
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2021

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: 72440808
• Device Catalogue Number: 72440808
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/03/2021
• Supplement Date Received by Manufacturer: 09/21/2021
• Initial Report FDA Received Date: 08/16/2021
• Supplement Report FDA Received Date: 09/22/2021
• 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; Other; Required Intervention