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

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

Patient Problems Post Operative Wound Infection (2446); Physical Asymmetry (4573)

Event Date 06/14/2021

Event Type  Injury  

Event Description

This report is being filed after the review of the following journal article: park j-g, et al.(2021), association of preoperative tibial varus deformity with joint line orientation and clinical outcome after open-wedge high tibial osteotomy, the american journal of sports medicine, volume 49, number 13, pages 3551-3560, ((b)(6)) this study aimed to compare the clinical and radiologic outcomes after open-wedge high tibial osteotomy (owhto) in patients without tibial varus deformity versus patients with tibial varus deformity after matching for confounding factors.Between january 2010 and october 2018, the outcomes of 133 owhto operations for medial osteoarthritis in 107 patients were retrospectively reviewed after following- up for more than 2 years.The patients were divided into group 1 (tibia with varus deformity, preoperative medial proximal tibial angle of less than 85 degrees and group 2 (tibia without varus deformity, preoperative medial proximal tibial angle of more than 85 degrees.Group 1 is composed of 68 patients with 19 males and 49 females with a mean age of 58.4 +/-4.9 years.Group 2 is composed of 65 patients with 15 males and 50 females with a mean age of 56.9 +/-5.1 years.During the osteotomy procedure, the proximal tibia was stabilized in the knee extension position using an unknown synthes tomofix osteotomy system.Passive and active knee range of motion exercises were encouraged after 2 days postoperatively.Gradual weight bearing was allowed from toe touch during the first 2 weeks to full weight bearing at 6 to 8 weeks.The following patients had complications and were excluded from the study: 2 patients had revision high tibial osteotomy.2 patients had surgical site infection.4 patients had displaced lateral hinge fractures.This report is for an unknown tomofix construct.This is report 1 of 1 for (b)(4).A copy of the clinical evaluation form is being submitted with this regulatory report.

Manufacturer Narrative

Additional narrative: group 1 is composed of 68 patients with 19 males and 49 females with a mean age of 58.4 +/-4.9 years.Group 2 is composed of 65 patients with 15 males and 50 females with a mean age of 56.9 +/-5.1 years.Exact date of event is unknown; (b)(6) 2021 is the date the literature article was published.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
• 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: 13905332
• MDR Text Key: 293150000
• Report Number: 8030965-2022-01949
• 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: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2022
• 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