GLASSVAN®
Report
- Report Number
- 8040409-2018-00003
- Event Type
- Malfunction
- Date Received
- April 9, 2018
- Date of Event
- February 27, 2018
- Report Date
- March 27, 2018
- Manufacturer
- NIRAJ INDUSTRIES PVT LTD.
- Product Code
- GES
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
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.
4/30/2020: G7: FOLLOW-UP NUMBER ADDED. H2: NOTED "REQUESTED BY FDA" FOR FOLLOW-UP TYPE. H4: MANUFACTURE DATE ADDED. H10: ADDITIONAL DATA ADDED.
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)
BLADE BROKE OFF IN PATIENT, WAS ABLE TO RECOVER.
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.
BLADE BROKE OFF IN PATIENT, WAS ABLE TO RECOVER.
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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 253194 | GLASSVAN® | BLADE | GES | NIRAJ INDUSTRIES PVT LTD. | 2001T-10 | 160908AC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |