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 Hematoma (1884); Post Operative Wound Infection (2446)

Event Type  Injury  

Manufacturer Narrative

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: bian, j.Et al.(2020), comparison of topical and intravenous tranexamic acid for high tibial osteotomy a retrospective study, medicine, vol.Xx, pages 1-6 (china).The objective of this study is to compare the operative bone bleeding of patients who underwent hto who received either intravenous (iv) or topical txa in this research.From january 2016 to august 2019, a total of 191 patients (including 72 who received iv txa, 64 who received topical txa and 55 control patients) underwent open-wedge hto using a locking plate (tomofix; depuy synthes, pa).There were 32 males and 159 females.The following complications were reported as follows: 1 patient had a tense wound hematoma, which was treated by surgical drainage.1 patient had a deep wound infection, which was treated with debridement, plate and screw removal, autologous iliac bone grafting and iv antibiotics.This report is for an unknown synthes tomofix.This report is for one (1) unk - constructs: tomofix plate/screws.This is report 1 of 1 for complaint (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: 12547169
• MDR Text Key: 273799658
• Report Number: 8030965-2021-08116
• 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,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/31/2021

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: 08/31/2021
• Initial Date FDA Received: 09/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention