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 Non-union Bone Fracture (2369); Post Operative Wound Infection (2446); Skin Inflammation/ Irritation (4545)

Event Type  Injury  

Manufacturer Narrative

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: kocialkowski c, et al.(2021), return to work after medial opening wedge high tibial osteotomy, journal of arthroscopy and joint surgery, volume 8, pages 193-201 (b)(6).The main objective of this study was to evaluate the return to work following medial opening-wedge high tibial osteotomy in our institution.Between 2004 and 2016, 42 patients (46 procedures) who underwent medial opening wedge high tibial osteotomy procedures for medial compartment knee osteoarthritis, medial joint pain, and varus malalignment were included in the study.The mean patient age was 46 years (range 33- 63) and 37 patients were male.The synthes tomofix plate was used in 36 procedures while the competitor¿s plate was used in 10.Postoperatively, patients underwent routine rehabilitation and were allowed to weight bear as tolerated.For the outcome assessment, patients received a questionnaire to assess work related function, overall quality of life and satisfaction with surgery by reporting how likely they would be to undergo the operation again.Additionally, the questionnaire included information about their type of employment and their return to work postoperatively.The article did not specify which patients were implanted with the synthes devices.Thus, complications will be reported as follows: 3 patients subsequently underwent knee arthroplasty (1 total knee arthroplasty and 2 unicompartmental knee arthroplasties).These revision procedures occurred at a mean 3.9 years (range 3-4.8 years) after the index high tibial osteotomy.11 patients subsequently underwent removal of metalwork due to soft tissue irritation.5 patients had superficial infection which responded to oral antibiotics.1 patient had deep wound infection which required removal of metalwork and application of a circular external fixation.1 patient had non-union which required revision high tibial osteotomy and bone graft.1 patient had a pulmonary embolism which was treated with anticoagulation.This report is for the synthes tomofix locking plate system.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: 12548230
• MDR Text Key: 274222101
• Report Number: 8030965-2021-08129
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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
• Report Date: 09/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2021
• 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
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention