MAUDE Adverse Event Report: SYNTHES GMBH UNK - CONSTRUCTS: LCP DISTAL FIBULA PLATE/SCREWS; PLATE, FIXATION ,BONE

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

Patient Problems Necrosis (1971); Discomfort (2330); Unspecified Tissue Injury (4559)

Event Type  Injury  

Manufacturer Narrative

There are multiple patients all information is provided in the article.This report is for an unknown lcp distal fibula plate/unknown lot.Part and lot number are unknown; udi number is unknown.Implant date is between (b)(6) 2012 to (b)(6) 2018.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

This report is being filed after the review of the following journal article: jung gh, et al.(2021), percutaneous bridge plating of extra-articular distal fibular fracture for the management of distal tibia type iii open fracture, asian journal of surgery, volume 44, pages 363-368, (south korea).The aim of this study is to conduct clinical and radiographic evaluations of the use of percutaneous bridge plating for distal fibular fractures combined with distal tibia type iii open fractures.From january 2012 to december 2018, 34 patients with concurrent distal fibular fractures with distal tibia type iii open fractures who underwent the percutaneous bridge plating for the fibula fractures were included in this study.There were 27 males and 7 females with a mean age of 50.6 years (range, 22-77 years).All distal tibia open fractures were temporally stabilized with a spanning external fixator, and concurrent fibular fractures were fixed with the percutaneous bridge plating simultaneously.Fibular fractures were stabilized with either an unknown synthes 2.7/3.5-mm distal fibula plate or an unknown synthes 3.5-mm locking compression plate (lcp).The average follow-up period was 19.9 ± 8.4 months (range, 13-38 months).Complications were reported as follows: 2 patients had superficial wound dehiscence in the distal window of the fibula.3 patients had superficial skin necrosis on the skin bridge between the open wound of the tibia fracture and incision of the fibula.They went through debridement and repetitive application of moist form dressings.19 patients had removal of the lcp distal fibula plates due to plate prominence and discomfort at the final follow-up.This report is for the unknown synthes 2.7/3.5-mm distal fibula plate or an unknown synthes 3.5-mm locking compression plate (lcp).This report is for one (1) unknown lcp distal fibula plate.This is report 1 of 2 for (b)(4).

• Brand Name: UNK - CONSTRUCTS: LCP DISTAL FIBULA PLATE/SCREWS
• Type of Device: PLATE, FIXATION ,BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12526239
• MDR Text Key: 273127592
• Report Number: 8030965-2021-07995
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: KS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/04/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention