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 Bone Fracture(s) (1870); Post Operative Wound Infection (2446); Physical Asymmetry (4573)

Event Date 05/04/2021

Event Type  Injury  

Manufacturer Narrative

A total of 37 patients had lateral hinge fracture which included 16 males and 21 females with a mean age of 58.53 +/-3.85 years (range 50 to 68), mean height of 159.76 +/- 8.14 cm (range 148 to 177), and mean weight of 66.52 +/-10.318 kg (range 53 to 90).Exact date of event is unknown; may 04, 2021 is the date the literature article was published.This report is for an unknown tomofix construct/unknown lot.Part and lot number are unknown; udi 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.

Event Description

This report is being filed after the review of the following journal article: lee s-j, et al.(2021), incidence and factors affecting the occurrence of lateral hinge fracture after medial opening-wedge high tibial osteotomy, the orthopaedic journal of sports medicine, volume 9, number 10, pages 1-5, (south korea).The purpose was to compare the incidence of lateral hinge fracture on plain radiographs versus computed tomography (ct) scans and to investigate the factors related to the development of lateral hinge fracture after medial opening-wedge high tibial osteotomy.Between january 2016 and december 2019, 70 patients (83 knees) with symptomatic medial compartment osteoarthritis with varus malalignment who underwent medial opening-wedge high tibial osteotomy and ct scans within 2 weeks after surgery were included in the study.A total of 37 patients had lateral hinge fracture which included 16 males and 21 females with a mean age of 58.53 +/-3.85 years (range 50 to 68), mean height of 159.76 +/- 8.14 cm (range 148 to 177), and mean weight of 66.52 +/-10.318 kg (range 53 to 90).Fixation of the osteotomy was performed using an unknown synthes tomofix plate without a gap filler.Patients were encouraged to start passive range of knee motion and active quadriceps strengthening exercises the day after surgery with hinged knee brace protection.Partial weightbearing with crutches and a brace was maintained for 4 weeks, followed by full weightbearing as tolerated.The mean follow-up duration was 2.7 ± 0.4 years (range, 2.2-3.0 years).The following patients had complications and were excluded from the study: 37 patients had lateral hinge fractures.3 patients had suspicious superficial wound infection.2 of them were treated via oral antibiotics administration while 1 underwent wound debridement with intravenous antibiotics treatment and the infection was alleviated without any problem.1 patient had undercorrection and worsening symptoms which required conversion to total knee arthroplasty 23 months after surgery.This report is for an unknown tomofix construct.This is report 1 of 1 for (b)(4).

• 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: 13905127
• MDR Text Key: 293529099
• Report Number: 8030965-2022-01945
• 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