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)

Event Date 04/16/2021

Event Type  Injury  

Manufacturer Narrative

510k: this report is for an unk - constructs: tomofix plate/screws/unknown lot.Part and lot numbers 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: liu t-w, et al.(2021), risk factor analysis for infection after medial open wedge high tibial osteotomy, journal of clinical medicine, volume 10, 1727, pages 1-9, (taiwan).This study aimed to identify the risk factors for infection after medial open wedge high tibial osteotomy combined with arthroscopic procedures.From june 2016 to may 2019, 59 consecutive patients who underwent medial open wedge high tibial osteotomy with a knee arthroscopic procedure were included in the study.There were 20 males and 39 females with a mean age of 58.7+/-6.9 years and a mean bmi of 27.2+/-3.6 kg/m2.The unknown synthes tomofix locking plate was used as the fixation device.A competitor¿s artificial bone graft was filled in the medial osteotomy site in all patients.A drainage tube with hemovac was placed in all patients and was typically removed on postoperative day 2.Partial weight bearing was allowed immediately after the surgery.No limitation in the range of motion was needed; therefore, the patients were not recommended to wear braces.Progression to full weight bearing was allowed six weeks after surgery, as tolerated by the patient.Complications were reported as follows: 8 patients had superficial surgical site infection.All of those were treated successfully with oral antibiotics for one week.A (b)(6) year-old male had a deep surgical site infection at 3 months after surgery.The patient was treated with arthroscopic debridement of the knee joint, open debridement of osteotomy site, and systemic antibiotics with daptomycin and ceftazidime for a total of 6 weeks.The case was treated successfully with preservation of plate fixation reached bony union after 8 months of follow-up.A (b)(6) year-old male had a deep surgical site infection at 2 weeks after surgery.Culture showed staphylococcus epidermis.The patient was treated with arthroscopic debridement of the knee joint, open debridement of osteotomy site, and systemic antibiotics with daptomycin for a total of 6 weeks.The case was treated successfully with preservation of plate fixation reached bony union after 8 months of follow-up.A (b)(6) year-old male patient had a deep surgical site infection at 2 months after surgery.Culture showed methicillin-susceptible staphylococcus aureus.The patient was treated with open debridement of osteotomy site and systemic antibiotics with oxaxillin for a total of 6 weeks.The case was treated successfully with preservation of plate fixation reached bony union after 8 months of follow-up.Patient also had a lateral hinge fracture as an intraoperative complication and underwent fixation with 2 unknown cannulated screws.This report is for the unknown synthes tomofix locking plate.This report is for one (1) unk - constructs: tomofix plate/screws.This is report 1 of 4 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: 12561668
• MDR Text Key: 274264080
• Report Number: 8030965-2021-08220
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: TW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2021
• 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: 09/01/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention