MAUDE Adverse Event Report: SMITH & NEPHEW, INC. EVOS 2.4MM Y-PLATE 5 HOLE HD 7 HOLE SFT PLATE, FIXATION, BONE

Model Number 72442484N

Device Problem Fracture (1260)

Patient Problems Failure of Implant (1924); Non-union Bone Fracture (2369); Insufficient Information (4580)

Event Date 02/25/2022

Event Type  Injury  

Event Description

It was reported that, after an internal fixation surgery, the evos 2. 4mm y-plate 5 hole head 7 hole shaft fractured. It is unknown how this situation was resolved, as well as the current health status of the patient.

Manufacturer Narrative

Internal complaint reference: (b)(4).

• Brand Name: EVOS 2.4MM Y-PLATE 5 HOLE HD 7 HOLE SFT
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 14605077
• MDR Text Key: 293432247
• Report Number: 1020279-2022-02753
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: CI
• PMA/PMN Number: K082516
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative

Reporter Occupation

• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/19/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 72442484N
• Device Catalogue Number: 72442484N
• Device Lot Number: 21JM17849
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/27/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 06/06/2022 Patient Sequence Number: 1

Treatment

PERI-LOC 4.5MM T25 LOCK SCREW 30MM S-T; PERI-LOC 4.5MM T25 LOCK SCREW 74MM S-T; PERI-LOC 4.5MM T25 LOCK SCREW 80MM S-T