MAUDE Adverse Event Report: SMITH & NEPHEW, INC. EVOS 4.7MM X 46MM OST SCR F-T; PLATE, FIXATION, BONE

Model Number	72424746
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Injury (2348)
Date of Event	01/07/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the thread pitch on the 4.7mm fully threaded osteopenia and partially threaded osteopenia screws are too aggressive and causing a number of issues such as not being able to fit through a plate hole other than at 90 degrees, the thread catch the plate, causing the plate to lift off the bone displacing/losing the reduction, the force to advance the screw causing the bone fragment to rotate and misalign which adds a further operation as the tension band wire needs to be removed, also the amount of metal exceeds the hole the drill makes causing the bone to split.
Additional Manufacturer Narrative
The devices, used in treatment, was not returned for evaluation and the reported event could not be confirmed.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the complaint history for the listed part revealed no prior complaints for the listed failure mode.The lot is unknown for these devices.A review of the risk management file and instructions for use document for this failure mode was conducted and concluded this failure mode has been identified.Our clinical/medical team noted: although the surgical technique addresses the specific differences of the 4.7mm osteopenia screws, it is unknown if the recommendations from the surgical technique was followed.The patient impact beyond the reported events (inadequate reduction, ¿causing the bone to split¿/bone fragmentation, additional device and procedure (banding & future removal)), and minor surgical extension could not be determined.No further medical assessment is warranted at this time.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 devices or additional information be received, the complaint will be reopened.No further investigation 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 4.7MM X 46MM OST SCR F-T
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9722401
• Report Number: 1020279-2020-00623
• Device Sequence Number: 2353296
• Product Code: HRS
• UDI-Device Identifier: 00885556637500
• UDI-Public: 00885556637500
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K162078
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2020

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: 72424746
• Device Catalogue Number: 72424746
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/21/2020
• Supplement Date Received by Manufacturer: 10/12/2020
• Initial Report FDA Received Date: 02/18/2020
• Supplement Report FDA Received Date: 11/04/2020
• 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