MAUDE Adverse Event Report: PEGA MEDICAL, INC. FASSIER-DUVAL INTERMEDULLARY SYSTEM; INTRAMEDULLARY NAIL

Catalog Number MR232-S

Device Problem Fracture (1260)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 07/11/2017

Event Type  Injury  

Manufacturer Narrative

This was a case of a (b)(6) patient with congenital pseudarthrosis of the tibia that had been treated using ø3.2 mm fd implant.While using the male retriever instrument to retrieve the male implant, the coil portion of the coil puller shaft broke due to impaction.At the time of the removal, significant growth had occurred and the female and male components of the fd system were fully separated.Normally, the male remains inside the female which shields the end of the male component thus allowing secure engagement of the male retriever during the retrieval process.Due to the separation of the male and female, there was bone growth around the implant making it difficult for the male retriever to engage the male component.According to information provided by the company representative present at the surgery and the surgeon, impaction was used to attempt engagement.The surgeon managed to engage partially the coil puller.They decided to remove the removal tool with plans to drill further over the male component.When do so, the removal tool had actually engaged strongly with the male rod.However, the coil puller shaft broke proximal to the interface and left a portion of the removal tool in the tibia, still attached to the male portion of the rod.The impaction and the pulling force with the instrument partially engaged caused the coil portion of the coil puller shaft to break in the process.The broken coil portion and the fd male implant were left in the patient.This instrument is not designed to be impacted.This incident appears as an isolated case due to specific circumstances of bone growth around the male component and undue impaction of the instrument.

Event Description

The event occurred during a surgery for removal of a 3.2 mm male component of the fassier-duval intermedullary system that was inserted inside the medullary canal of the tibia.While attempting to engage the male retriever instrument to retrieve the implant, the coil portion of the coil puller shaft of the male retriever instrument broke.The broken coil portion and the male implant were left in the patient.

• Brand Name: FASSIER-DUVAL INTERMEDULLARY SYSTEM
• Type of Device: INTRAMEDULLARY NAIL
• Manufacturer (Section D): PEGA MEDICAL, INC.; 1111 autoroute chomedey; laval, quebec H7W 5 J8; CA H7W 5J8
• Manufacturer (Section G): PEGA MEDICAL, INC.; 1111 autoroute chomedey; laval, quebec H7W 5 J8; CA H7W 5J8
• Manufacturer Contact: enrique garcia ; 1111 autoroute chomedey; laval, quebec H7W 5-J8 ; CA H7W 5J8
• MDR Report Key: 6771648
• MDR Text Key: 81961778
• Report Number: 3000327445-2017-00004
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020885
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: MR232-S
• Device Lot Number: 160308-11
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/12/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/23/2016
• 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
• Patient Outcome(s): Other
• Patient Age: 7 YR