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

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

Patient Problems Injury (2348); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown narrow 3.5mm lapping/dynamic compression 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.(b)(4).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: mahdi s, et al (2019) humeral shaft fracture: a randomized controlled trial of nonoperative versus operative management (plate fixation), orthopedic research and reviews volume 11,pages 141¿147 (iran) doi: 10.2147/orr.S212998.This randomized clinical trial aims to compare clinical, functional, and radiological outcomes and the rate of complications among hsf patients treated with orif versus those receiving a functional sarmiento brace.Between january and december 2016, a total of 60 patients with isolated hsfs were included in the study.Patients were divided into two equal groups:30 patients (23 males, 7 females) age 37.7±15.4 years (18¿71 range) were in the operative treatment (orif) group, fixation was done using a narrow lapping/dynamic compression plate of 3.5 mm and the non-operative group with 30 patients (26 males, 4 females) age 48.5±19.4 years (19¿77 range) using a functional brace called sarmiento.Patients were examined at the beginning of the study and weeks 2 and 4 after the treatment.The following complications were reported as follows: among the 30 eligible patients assigned to the operative group, 18 were identified with neuroapraxia that was transient and fully resolved within 3¿6 months of conservative management.This report is for an unknown synthes narrow 3.5 mm lapping/dynamic compression plate construct.This is report 1 of 1 for complaint (b)(4).

• Brand Name: UNK - CONSTRUCTS: 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: 10871357
• MDR Text Key: 217367354
• Report Number: 8030965-2020-09094
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: IR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2020
• 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: 10/27/2020
• 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