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 Bone Fracture(s) (1870); Hematoma (1884); Pain (1994); Impaired Healing (2378)

Event Type  Injury  

Event Description

This report is being filed after the review of the following journal article: li, s.Et al (2021), not using a tourniquet is superior to tourniquet use for high tibial osteotomy: a prospective, randomised controlled trial, international orthopaedics, vol.Xx (xx), pages 1-7 ((b)(6)).The aim of this prospective, randomised controlled study was to evaluate the effect of the use of a tourniquet during hto on post-operative blood loss, the complication rate and early functional recovery of the affected limb.Between november 2019 to may 2021, a total of 90 patients who underwent medial open wedge high tibial osteotomy (owhto) were included in the study.The patients were randomised into group a (non-tourniquet, n=45 [20 male and 25 female; mean age=59.68 ± 8.34 years]) and group b (tourniquet, n=45 [16 male and 29 female; mean age=58.80 ± 8.33 years]).Surgery was performed using a tomofix locking plate (depuy synthes, (b)(6)).All patients were followed up for more than three months.The following complications were reported: 10 patients had thigh complications.4 patients developed deep vein thrombosis.1 patient had lateral hinge fracture.8 patients had wound complications.In group a, one patient had delayed wound healing, and one patient had incision oozing and delayed healing due to suture hypersensitivity.In group b, six patients had incision complications, including four cases of delayed healing and two cases of subcutaneous haematoma.Group a patients with suture hypersensitivity were readmitted on day 20 after the operation to resuture the incision.23 patients required morphine.This report is for an unknown synthes tomofix medial high tibia plate/screws constructs.A copy of the literature article is being submitted with this medwatch.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

There are multiple patients.All known information is presented in the literature article.This report is for an unknown medial high tibia tomofix plate and screws construct/unknown lot.Part and lot number are unknown; udi number is unknown.There are multiple unknown dates of implantation between november 2019 and may 2021.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: 13906620
• MDR Text Key: 291387973
• Report Number: 8030965-2022-01964
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 02/25/2022
• Initial Date FDA Received: 03/25/2022
• 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