MAUDE Adverse Event Report: M/S NIRAJ INDUSTRIES PVT LTD. GLASSVAN; SURGICAL BLADE

Catalog Number 3001T-15

Device Problems Break (1069); Fracture (1260)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/15/2015

Event Type  malfunction  

Manufacturer Narrative

The investigation into a root cause is ongoing.The manufacturer is testing retain samples of this lot currently and will update this report.Device not returned to the manufacturer.

Event Description

The oral surgeon stated he had 2 blades break during the initial incision on one patient while performing an impacted wisdom tooth procedure.The blade fractured at the handle cutout but no fragment was left in the patient.The second blade prepared for the same patient fractured in the same manner, so he used a blade from a different box with no incident.He could not confirm the brand or lot of the alternate third blade used.On a second patient, the surgeon had a blade tip break in the patient's gum and removed the fragment using a hemostat.The surgeon stated that no harm came to either patient.The oral surgeon stated that he was not sure of the brand of the blade, but he had his staff remove the remainder of that box and send it back to their distributor.We have attempted to obtain these samples back from the distributor, but the blades were unavailable when the delivery driver attempted pick up.We will continue to try to retrieve the samples or confirm they have been discarded or lost.

Manufacturer Narrative

Correction: date of event on initial submission incomplete.Although the actual date of the events were not specific by the end-user, we list here the date the complaint was received for reference.This is an approximate date of the event as the surgeon was not sure of the exact date which these events occured.Additional narrative: the defect devices were discarded by the end-user.The remainder of the box of blades was returned from the distributor and evaluated by the manufacturer.The blades from the same box were used in the evaluation and it was concluded that "no crack / broken blades observed on visual examination.Hardness and stiffness (break angle) of all samples observed with in specification." the manufacturer's report is attached to this file for review.No similar complaints or reports from this or any other batch were reported to date.The manufacturer has concluded their investigation, and we consider this issue closed.

Event Description

The oral surgeon stated he had 2 blades break during the initial incision on one patient while performing an impacted wisdom tooth procedure.The blade fractured at the handle cutout but no fragment was left in the patient.The second blade prepared for the same patient fractured in the same manner, so he used a blade from a different box with no incident.He could not confirm the brand or lot of the alternate third blade used.On a second patient, the surgeon had a blade tip break in the patient's gum and removed the fragment using a hemostat.The surgeon stated that no harm came to the patient.The oral surgeon stated that he was not sure of the brand of the blade, but had his staff remove the remainder of that box and send it back to the distributor.We have attempted to obtain these samples back from the distributor, but the blades were unavailable when the delivery driver attempted pick up.We will continue to try to retrieve the samples or confirm they have been discarded or lost.

• Brand Name: GLASSVAN
• Type of Device: SURGICAL BLADE
• Manufacturer (Section D): M/S NIRAJ INDUSTRIES PVT LTD.; plot 177, sector 25; ballabgarth, faridabad 12100 4; IN 121004
• Manufacturer (Section G): M/S NIRAJ INDUSTRIES PVT LTD.; plot 177, sector 25; ballabgarth, faridabad 12100 4; IN 121004
• Manufacturer Contact: rajiv nath ; plot 177, sector 25; ballabgarh, faridabad 121 0-04 ; IN 121 004 ; 294289000
• MDR Report Key: 5223627
• MDR Text Key: 31454879
• Report Number: 8040409-2015-00006
• Device Sequence Number: 1
• Product Code: GES
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/06/2015,01/06/2016

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: Other
• Device Expiration Date: 03/01/2020
• Device Catalogue Number: 3001T-15
• Device Lot Number: 151104AC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/06/2015
• Distributor Facility Aware Date: 10/15/2015
• Device Age: 7 MO
• Event Location: Other
• Date Report to Manufacturer: 10/16/2015
• Initial Date Manufacturer Received: 10/16/2015
• Initial Date FDA Received: 11/13/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/06/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2015
• 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