MAUDE Adverse Event Report: NIRAJ INDUSTRIES PVT LTD. GLASSVAN® BLADE

Model Number 2001T-10

Device Problem Break (1069)

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

Event Date 02/27/2018

Event Type  malfunction  

Event Description

It was reported that the blade broke off in patient while performing a knee arthroplasty. The clinician was able to recover the fragment and no harm came to the patient.

Event Description

Blade broke off in patient, was able to recover.

Manufacturer Narrative

Reference the below report sections for additional information reflecting the update of this mdr event: device available for evaluation: updating this mdr report to reflect the manufacturer's acknowledgement receiving the defective device being discussed in this mdr for evaluation. Therefore, 'yes' is being selected. Type of report: the follow-up# is being updated to 003 to reflect the current follow-up# of this mdr event. The 'date received by manufacturer' is being updated to 03-may-2018 to reflect the date the manufacturer will receive this follow-up report (003). Type of report: the follow-up# is being updated to 003 to reflect the current follow-up# of this mdr report. 'yes' and 'evaluation summary attached' is selected to reflect the 'device evaluated by manufacturer'. Providing clarification as the device mentioned in this mdr report is labeled for 'single use'; therefore, 'single use' is being selected. Referenced in the previous follow-up report (002), the manufacturer's narrative is documented. The manufacturer, niraj industries pvt. Ltd received the reported defective device for evaluation. As referenced in the attached evaluation summary, observation of characteristics did not indicate any potential of blade breaking during normal use. Therefore, based off the manufacturer's investigation results provided within this mdr reports, we are moving to close this complaint file and consider this mdr closed. (b)(4).

Manufacturer Narrative

Along with the manufacturer's narrative, additional information in the sections referenced below have been added to this follow-up mdr report: this follow-up report includes the manufacturer's report#. This follow-up report includes the manufacturer's report#; therefore, section g will be completed with provided information. This follow-up report includes the manufacturer's report#. Manufacturer's narrative: the manufacturer, niraj industries pvt ltd. , was notified of the complaint reported as highlighted in this mdr report. Currently, the reported defective device has not been returned to the manufacturer, however, an examination of retain samples for item#2001t-10/lot#160908ac located at the manufacturer has been conducted. The product parameters which can induce or result in breakage of blade (i. E. Hardness, stiffness & lack of sharpness) has been observed to be within specified limit on evaluation of retained sample of complaint batch and related records of a manufacturing & inspection. The only potential reason for the reported event could be an excessive lateral force application at the time of use. For cautionary measure, all related persons have been educated to take care at all possibilities of blade breakage during process & inspection. This mdr will be updated as pertinent information is received about this event.

Event Description

Blade broke off in patient, was able to recover.

• Brand Name: GLASSVAN®
• Type of Device: BLADE
• Manufacturer (Section D): NIRAJ INDUSTRIES PVT LTD.; plot 177, sector 25; ballabgarth, faridabad harayana 12100 4; IN 121004
• MDR Report Key: 7409474
• MDR Text Key: 194149334
• Report Number: 8040409-2018-00003
• Device Sequence Number: 1
• Product Code: GES
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/27/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 04/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 07/01/2021
• Device Model Number: 2001T-10
• Device Lot Number: 160908AC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2018
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/27/2018
• Distributor Facility Aware Date: 03/27/2018
• Device Age: 20 MO
• Event Location: Hospital
• Date Report to Manufacturer: 03/29/2018
• Date Manufacturer Received: 05/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No