• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services


  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

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.
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Type of DeviceBLADE
Manufacturer (Section D)
plot 177, sector 25
ballabgarth, faridabad harayana 12100 4
IN 121004
MDR Report Key7409474
MDR Text Key194149334
Report Number8040409-2018-00003
Device Sequence Number1
Product Code GES
Combination Product (y/n)N
Number of Events Reported1
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 Received04/09/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/01/2021
Device Model Number2001T-10
Device Lot Number160908AC
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/18/2018
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/27/2018
Distributor Facility Aware Date03/27/2018
Device Age20 MO
Event Location Hospital
Date Report to Manufacturer03/29/2018
Date Manufacturer Received05/03/2018
Is This a Reprocessed and Reused Single-Use Device? No