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 Problem Physical Asymmetry (4573)

Event Type  Injury  

Event Description

This report is being filed after the review of the following journal article: ryu, d.J.Et al (2021), reliability of preoperative planning method that considers latent medial joint laxity in medial open-wedge proximal tibial osteotomy, the orthopaedic journal of sports medicine, vol.9 (10), pages 1-9 (korea, south).The purpose of this retrospective cohort study was to (1) quantify medial laxity and develop a preoperative planning method that considers medial laxity and (2) develop an equation to reduce coronal correction error in terms of preoperative medial soft tissue laxity.Between january 2014 to july 2019, a total of 154 knees in 131 patients underwent navigation-assisted medial open-wedge proximal tibial osteotomy (mowpto).Among these, 139 knees (48 male and 91 female) in 117 patients with a mean age of 54.4 (33 to 65) years were included in the study.The proximal tibia was fixed using a locking plate (tomofix; depuy synthes).The patients visited the outpatient clinic at 6 weeks, 3 months, and 6 months postoperatively.The mean follow-up period was unknown.The following complications were reported as follows: 3 knees underwent revision operations attributed to revarization after mowpto.47 knees were overcorrected.8 knees were undercorrected.This report is for an unknown synthes tomofix medial high tibia plate/screws.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

This report is for an unknown tomofix plate/screws: medial high tibia construct/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 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 13922528
• MDR Text Key: 293165271
• Report Number: 8030965-2022-01965
• 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,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2022
• 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: 02/25/2022
• 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