MAUDE Adverse Event Report: SYNTHES GMBH UNK - RAPIDSORB IPS IMPLANTS; PLATE, BONE

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

Patient Problem Unspecified Tissue Injury (4559)

Event Type  Injury  

Event Description

This report is being filed after the review of the following journal article: kamran, a.A smithers, c.J.B.Baird, c.W.,c and jennings, r.W.(2021), experience with bioresorbable splints for treatment of airway collapse in a pediatric population, jtcvs techniques,, vol.8(x) 160-169 (usa).The aim of this retrospective study was to report our experience with novel external tracheal and bronchial placed bioresorbable splints in children with severe symptomatic airway collapse.Between july 2018 and february 2020, a total of 14 patients [9 males and 5 females, with mean age of 14.5 months (range, 2 months-14 years)] who underwent surgical treatment for symptomatic airway collapse received external bioresorbable splint were included in this study.All patients were symptomatic and had bronchoscopic evaluation demonstrating severe airway narrowing due to tracheobronchomalacia and/or airway compression.7 patients had tracheostomies, 6 of them were dependent on mechanical ventilation with pressures too high to go home.7 patients had cardiovascular comorbidity causing airway compression, and there were 2 patients with a significant decrease in thoracic space due to a chest wall deformity.Bioresorbable splints were placed at the trachea (n = 8), left mainstem bronchus (n = 7), and/or right mainstem bronchus (n = 1).Splints were formed from readily available moldable bioresorbable plates (rapidsorb; synthes, oberdorf, switzerland) and were customized intraoperatively around a hegar dilator 2 to 3 mm larger than the external diameter of the airway after dipping into 70 degree celsius saline solution two patients had splints placed in more than 1 location.Concomitant procedures included posterior tracheobronchopexy (n = 7), anterior tracheobronchopexy (n = 5), anterior aortopexy (n = 5), and slide tracheobronchoplasty (n = 2), and rotation esophagoplasty (n = 7).Six patients with a cardiovascular anomaly causing airway compression and 2 patients with a chest wall deformity had combined procedures during the same surgery.The median follow-up was 20 months (interquartile range, 12-21 months).The following complications are reported as follows: -patient 5 died five days postoperatively with patent airways; due to congenital heart disease.-patient 12 died three months postoperatively with patent airways; due to multiple congenital comorbidities.-patient 2 had right lung ventilation¿ perfusion mismatch (due to right lung underlying pathology and pulmonary artery agenesis), tracheal stenosis after reconstruction.-patient 3 had desaturation spells while crying.Posterior tracheobronchopexy (t2, t3, lmb), tracheostomy (persistent cervical tracheomalacia; 5 mo after splint placement) was performed.-patient 4 had bronchial splint fracture, subglottic stenosis.Bronchial splint replacement, posterior bronchopexy (lmb, revision), tracheostomy were performed.-patient 6 had persistent cervical tracheomalacia.Tracheostomy was performed.-patient 7 had severe distal small airways bronchomalacia.Tracheostomy was performed.-patient 9 had laryngomalacia (residual laryngeal cleft), vocal cord paralysis.Tracheostomy was performed.-patient 12 had multilevel airway narrowing: paralyzed left vocal cord, subglottic stenosis, persistent cervical tracheomalacia.Tracheostomy was replaced.A copy of the literature article is being submitted with this medwatch.This report involves one unk - rapidsorb ips implants.This is report 2 of 7 for (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: d1, d2a, d2b, d3, d4, g4 ¿ 510k: this report is for an unknown rapidsorb ips implants/unknown lot.Part and lot numbers are unknown; udi number is unknown.D9: complainant part is not expected to be returned for manufacturer review/investigation.H3, h4, h6: 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.

• Brand Name: UNK - RAPIDSORB IPS IMPLANTS
• Type of Device: PLATE, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 18748006
• MDR Text Key: 335931723
• Report Number: 8030965-2024-02644
• Device Sequence Number: 1
• Product Code: JEY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2024
• 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: 02/06/2024
• 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