MAUDE Adverse Event Report: ORTHOPEDIATRICS, CORP PEDINAIL IM PLATFORM; ADOLESCENT NAIL ATTACHMENT BOLT

Catalog Number 01-1503-0032

Device Problem Mechanical Jam (2983)

Patient Problem No Code Available (3191)

Event Date 06/20/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Complaint sample was returned for evaluation.Reported event was confirmed.Risk management file review was deemed appropriate.The root cause of the reported bolt seizure was found to be the application of off-axis loading during bolt assembly which leads to a bending moment across the threaded junction.This bending moment results in increased and non-uniform loading within the threads, leading to damage and adhesion between the components.Concomitant devices proximal targeting guide adolescent nail: item number; 01-1503-0002, lot number; 201906-c; guide rod obturator: item number; 01-1501-0014, lot number; 1417101-a; 9mm x 360mm adolescent nail, left: item number; 00-1503-0936, lot number; 1785726-b.

Event Description

It was reported that during surgery, the proximal targeting guide, adolescent nail attachment bolt and adolescent nail, left became stuck and were unable to be disconnected.No adverse events have been reported as a result of the malfunction.

• Brand Name: PEDINAIL IM PLATFORM
• Type of Device: ADOLESCENT NAIL ATTACHMENT BOLT
• Manufacturer (Section D): ORTHOPEDIATRICS, CORP; 2850 frontier drive; warsaw, in
• Manufacturer (Section G): ORTHOPEDIATRICS, INC; 2850 frontier drive; warsaw, in
• Manufacturer Contact: leigh jessop ; 2850 frontier drive; warsaw, ; 2670872
• MDR Report Key: 9715091
• MDR Text Key: 190693274
• Report Number: 3006460162-2020-00026
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172583
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 01-1503-0032
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/20/2019
• Initial Date FDA Received: 02/15/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1