MAUDE Adverse Event Report: SYNTHES GMBH UNK - CONSTRUCTS: TOMOFIX PLATE/SCREWS: MEDIAL HIGH TIBIA; PLATE, FIXATION, BONE

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

Patient Problems Non-union Bone Fracture (2369); Post Operative Wound Infection (2446)

Event Date 01/01/2021

Event Type  Injury  

Event Description

This report is being filed after the review of the following journal article: wu k et al.(2021), effect of the amount of correction on posterior tibial slope and patellar height in open-wedge high tibial osteotomy, journal of orthopaedic surgery, volume 29, number 3, pages 1-10, doi: 10.1177/23094990211049571 (china).This study aimed to elucidate the influence of different amount of corrections on the changes pts (posterior tibial slope), ph (patellar height), and clinical outcomes in vivo after owhto (open-wedge high tibial osteotomy) for the first time.Between november 2015 to june 2019, 79 knees (32 left and 47 right) of 79 patients (mean age 60.28 ± 4.2 years, 24 males, 55 females) with varus malalignment and symptomatic isolated medial joint osteoarthritis who underwent owhto were included in the study.The medial tibia was fixed with unknown synthes tomofix medial high tibial plate for all patients.The mean follow-up period was 28.5 months (range 18¿52 months).Complications were reported as follows: 5 patients had non-displaced fractures within the tibiofibular joint intraoperatively.Fixation was performed with long metaphyseal cancellous bone screws followed by 4 weeks of delayed postoperative mobilization exercises.Finally, these patients were observed without obvious functional deficit.2 patients had superficial infections, which resolved completely with intravenous antibiotics therapy and wound dressing change.This report is for the unknown synthes tomofix medial high tibial plate osteotomy system.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

This report is for an unknown constructs: tomofix plate/screws: medial high tibia/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.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.

• Brand Name: UNK - CONSTRUCTS: TOMOFIX PLATE/SCREWS: MEDIAL HIGH TIBIA
• 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: 13941406
• MDR Text Key: 293166198
• Report Number: 8030965-2022-02020
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2022
• 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: 02/28/2022
• 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