MAUDE Adverse Event Report: SYNTHES GMBH UNK - CONSTRUCTS: MATRIXRIB PLATE/SCREWS; PLATE, FIXATION, BONE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Post Operative Wound Infection (2446)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown matrixrib locking plate construct/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k 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: zhang d, et al.(2021), minimally invasive surgery rib fracture fixation based on location and anatomical landmarks, european journal of trauma and emergency surgery, pages 1-10 (china).This study aimed to clarify the definition of zhang zhifei (zzf) zoning method, and to retrospectively analyze the clinical efficacy of zzf zoning method on the selection of incision and approach in 110 selected patients undergoing minimally internal fixation for rib fracture.From july 2017 to july 2019, 110 rib fracture patients with 3 or more unilateral dislocations (axial ct chest imaging measurements represented 50 percent of the rib width) and underwent selective open reduction and internal fixation for rib fractures were included in the study.There were 73 males and 37 females with a mean age of 52 years (range, 25-73 years).Pure titanium embracing fixator or pre-shaped rib locking plate was selected for fixation according to the anatomical characteristics and operation of the fracture site which included the unknown synthes matrixrib locking plate.During the operation, a 14f drainage tube was routinely placed between the rib surface muscle layers of the chest wall.In patients with parietal pleura damage, 22f closed thoracic drainage tube was placed in the 6th or 7th intercostal space of the mid-axillary line the drainage tube in chest wall was pulled out within 48 hours postoperatively.If the thoracic drainage volume was less than 100 ml at 24 h ours after the operation, and if there was no obvious liquid pneumothorax after re-examination of chest line or computed tomography of lung inflation, the closed thoracic drainage tube was pulled out.The article did not specify which patients were implanted with the synthes devices.Thus, complications will be reported as follows: 2 patients had postoperative wound infections, both healed in a short-term period after active dressing changes.2 patients had subcutaneous effusion that were cured by multiple suction and pressure dressing.1 patient had a removal of internal fixation 1 year after the operation due to continuous chest pain.The pain was significantly relieved and ultimately disappeared 3 months later.This report is for the unknown synthes matrixrib locking plate construct.This is report 1 of 1 for complaint (b)(4).

• Brand Name: UNK - CONSTRUCTS: MATRIXRIB 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 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 12501871
• MDR Text Key: 272437352
• Report Number: 8030965-2021-07888
• 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: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2021
• 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: 08/23/2021
• 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