MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN TRAUMA & EXTREMITIES DEV; PLATE, FIXATION, BONE

Catalog Number UNKN02000000

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

Patient Problems Unspecified Infection (1930); Deformity/ Disfigurement (2360); Limb Fracture (4518)

Event Date 02/01/2019

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference (b)(4).

Event Description

It was reported that on literature review ""gradual correction of proximal tibia deformity for blount disease in adolescent and young adults"", 5 patients, who were treated with either an ilizarov or taylor spatial frame external fixator as part of a gradual correction of neglected blount disease, had several complications afterwards which required a specific intervention to be resolved.Two patients developed a pin site infection which was treated with oral antibiotics.In addition, two patients had a fracture at the osteotomy site after removal of the fixator frames.Both of these patients required an additional surgery to reapply with an external fixator and the fractures eventually reduced without bone grafting.There was also one patient that had a significant overcorrection of mechanical axis deviation of 28.2 mm (lateral to knee joint center) following premature removal of the frame.This patient subsequently underwent acute corrective with closing wedge osteotomy and internal fixation.Details on the final outcome for all of these patients are unknown at this time.No further information is available.

Manufacturer Narrative

H3, h6: the devices were not returned for evaluation and the reported events could not be confirmed.The clinical/medical investigation concluded that, without clinically relevant patient-specific supporting documentation, a thorough medical investigation could not be performed.The images provided in the article have been interpreted within the text; therefore, no further analysis of the images are required.The root cause and/or patient outcome beyond that which was documented in the article could not be confirmed nor concluded; therefore, no further medical assessment is warranted at this time.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.Possible causes could include but are not limited to contamination, patients reaction, post-operative healing issue, excessive forces applied to implant, surgical technique used, size of device or user/procedural variance.The contribution of the devices to the reported events could not be corroborated.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual products involved, our investigation could not proceed.Should the devices 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: UNKN TRAUMA & EXTREMITIES DEV
• 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: 13637992
• MDR Text Key: 287672600
• Report Number: 1020279-2022-00955
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: MY
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKN02000000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention