MAUDE Adverse Event Report: SYNTHES GMBH UNK - CONSTRUCTS: HUMERAL NAIL; NAIL, FIXATION, BONE

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

Patient Problems Discomfort (2330); Non-union Bone Fracture (2369)

Event Type  Injury  

Manufacturer Narrative

(b)(4).This report is for an unknown humeral nail/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: wang y, et al.(2020), comparison between osteosynthesis with interlocking nail and minimally invasive plating for proximal- and middle-thirds of humeral shaft fractures, international orthopaedics, pages 1-10 (china) this study aimed to compare intramedullary interlocking nail (imn) with minimally invasive plate osteosynthesis (mipo) in terms of the surgical effectiveness and potential risks of treating proximal- and middle-thirds of humeral shaft fractures.From january 2012 to january 2016, 55 patients with proximal- and middle-thirds of humeral shaft fractures treated using imn or mipo were included in this study.There were 33 males and 22 females with a mean age of 38.9 years (range, 18-56 years).Of all the patients, 30 were treated with mipo using an unknown synthes long proximal humerus internal locking system plate (philos) and 25 were treated with antegrade interlocking nailing using an unknown synthes solid humerus nail uhn.The imn group comprised 16 males and nine females, and the mipo group comprised 17 males and 13 females.Post-operative management included limb elevation until the swelling subsided.The arms were immobilized with a neckwrist sling, and the patients were instructed to move the shoulders and elbows as early as 3 days after surgery.The stitches were removed 2 weeks after surgery.Follow-ups were conducted each month, and plain radiographs were obtained every month until evidence of fracture healing was confirmed.All the patients in both the mipo group and the imn group completed the follow up, and all of them were followed up for at least one year.Complications were reported as follows: imn group 5 patients had their hardware or implants surgically removed from 12th month to 15th month after surgery, with complaints of pain, irritation, or psychological reasons.1 patient failed to achieve union.This was managed by hardware replacement following with orif by screws and plate fixation, as well as bone grafting.1 patient had shoulder impingements and rotator cuff injury by physical examination.Mipo group: 17 patients had their hardware or implants surgically removed from 12th month to 15th month after surgery, with complaints of pain, irritation, or psychological reasons.2 patients failed to achieve union.This was managed by hardware replacement following with orif by screws and plate fixation, as well as bone grafting.3 patients had iatrogenic radial nerve palsy.All fully recovered within 3 months without surgical intervention.2 patients had humeral varus deformity with varus angle of about 5 degrees, which fortunately did not affect their daily life.This report is for an unknown synthes solid humerus nail uhn.It captures the reported events of implant removed due to pain, irritation, failed to achieve union, revised.A copy of the literature article is being submitted with this medwatch.This is report 1 of 2 for (b)(4).

• Brand Name: UNK - CONSTRUCTS: HUMERAL NAIL
• Type of Device: NAIL, 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: 11960145
• MDR Text Key: 267238881
• Report Number: 8030965-2021-04681
• Device Sequence Number: 1
• Product Code: JDS
• 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: 05/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2021
• 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: 05/14/2021
• 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