VNGD HIFLEX TRL RED TRAY 75MM
Report
- Report Number
- 3002806535-2020-00122
- Event Type
- Malfunction
- Date Received
- March 9, 2020
- Date of Event
- February 13, 2020
- Report Date
- November 25, 2021
- Manufacturer
- BIOMET UK LTD.
- Product Code
- JWH
- PMA / PMN Number
- N/A
- Removal / Correction Number
- N/A
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
(B)(4). THIS FINAL REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. G3: REPORT SOURCE, FOREIGN - EVENT OCCURRED IN JAPAN. DUE TO CIRCUMSTANCES SURROUNDING THE COVID-19 PANDEMIC, COMPLAINT PRODUCT EVALUATION CANNOT BE PERFORMED AT THIS TIME. HOWEVER, PHOTOGRAPHS OF SUFFICIENT QUALITY ARE AVAILABLE TO INVESTIGATE THE EVENT. SUMMARY OF INVESTIGATION: THE EVENT REPORTS THAT DURING THE PROCEDURE, AS THE SURGEON REMOVED THE TRIAL TRAY, THE PROTRUDING PART THAT HOOKS THE REMOVAL TOOL WAS FRACTURED INSIDE THE PATIENT BODY. THE FRACTURED PART WAS NOT ABLE TO BE REMOVED FROM THE PATIENT. THE FRACTURE / DAMAGE REPORTED ON THE LOCATING POST OF THE TRIAL REDUCER TRAY IS CONFIRMED. VISUAL INSPECTED THE PHOTOGRAPHS TO VERIFY ITEM AND LOT NUMBER. THE PRODUCT EXHIBITS SIGNS OF REPEATED USE; NICKS, GOUGES AND SCRATCH MARKS. THE PRODUCT HAS BEEN IN THE FIELD FOR APPROXIMATELY 10 YEARS. A REVIEW OF THE COMPLAINT DATABASE FOR THE ITEM # / LOT # COMBINATION HAS FOUND NO SIMILAR REPORTED COMPLAINTS. A REVIEW OF THE COMPLAINTS DATABASE FOR 3 YEARS PRIOR TO THE NOTIFICATION DATE AND UP TO AND INCLUDING 06 MAY 2020 HAS FOUND ONE SIMILAR REPORTED COMPLAINT FOR ITEM NUMBER 32-422204. THE DHR RELATED TO THE INVOLVED PRODUCT HAS BEEN REVIEWED AND DOES NOT SHOW ANY NON-CONFORMITY, REJECTION OR CONCESSION THAT COULD BE RELATED TO THE REPORTED EVENT. THE DEVICE WAS MOST LIKELY CONFORMING WHEN IT LEFT ZIMMER BIOMET CONTROL. THE REPORTED EVENT IS COVERED BY RISK MANAGEMENT FILE KNEE.INSTR.RMR REV 3. THE SEVERITY OF THE REPORTED EVENT IS IN LINE WITH THIS RISK FILE. REPROCESSING INSTRUCTIONS: REUSABLE SURGICAL INSTRUMENTS CAT, NO. 5401000246 VERSION 2.3 (MARCH 2009). THE INSTRUCTIONS FOR REUSABLE SURGICAL INSTRUMENTS WARNS THAT: MAINTENANCE, INSPECTION AND FUNCTIONAL TESTING: ALL INSTRUMENTS SHOULD BE VISUALLY CHECKED FOR DAMAGE AND WEAR. REUSABLE INSTRUMENT LIFESPAN MANUAL, PROVIDES VERBAL INSTRUCTION WITHIN THE INTRODUCTION SECTION HEADED INSPECTION/FUNCTION TESTING TO GUIDE THE USER ON HOW TO CHECK INSTRUMENTS FOR COMPLETENESS AND FUNCTION. VISUAL EXAMPLES OF DAMAGE CAN BE SEEN IN THE SECTION HEADED FRACTURE. CORRECTIVE ACTION TAKEN: NO CORRECTIVE ACTION REQUIRED AT THIS TIME. PREVENTIVE ACTION TAKEN: NO PREVENTIVE ACTION REQUIRED AT THIS TIME. SHOULD THE COMPLAINT PRODUCT BECOME AVAILABLE FOR INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED AND INVESTIGATED FULLY.
(B)(4). THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION FOLLOWING EVALUATION OF THE PRODUCT. IT WAS REPORTED THAT OPERATION WAS PERFORMED WITH VG PSRP ON (B)(6) 2019. DURING THE PROCEDURE, AS THE SURGEON REMOVED THE TRIAL TRAY, THE PROTRUDING PART THAT HOOKS THE REMOVAL TOOL WAS FRACTURED INSIDE THE PATIENT BODY, THE FRACTURED PART WAS NOT ABLE TO REMOVE FROM THE PATIENT. THIS OCCURRED IN SURGERY. A VISUAL CHECK OF THE RETURNED PRODUCT VANGUARD HI-FLEX TRIAL RED TRAY 75MM (ITEM 32-422204 LOT. ZB100902) CONFIRMS THAT THE TOP OF THE LOCATION PEG HAS FRACTURED OFF. THE PRODUCT EXHIBITS SIGNS OF REPEATED USE; NICKS, GOUGES AND SCRATCH MARKS. THE PRODUCT HAS BEEN IN THE FIELD FOR APPROXIMATELY 10 YEARS. THE MOST LIKELY ROOT CAUSE IS WEAR AND TEAR DUE TO BEING USED IN MANY SURGICAL PROCEDURE OVER THE 10 YEARS IN THE FIELD BUT THIS CANNOT BE CONFIRMED. REUSABLE INSTRUMENT LIFESPAN MANUAL (1219.4-GLBL-EN-ISSUE DATE 2021-04-08) PROVIDES VERBAL INSTRUCTION WITHIN THE INTRODUCTION SECTION HEADED INSPECTION/FUNCTION TESTING TO GUIDE THE USER ON HOW TO CHECK INSTRUMENTS FOR COMPLETENESS AND FUNCTION. VISUAL EXAMPLES OF DAMAGE CAN BE SEEN IN THE SECTION HEADED FRACTURE. THIS PRODUCT LEFT ZIMMER BIOMET CONTROL CONFORMING. A VISUAL INSPECTION OF THIS DEVICE SHOWS THIS EVENT DOES NOT DIFFER FROM PREVIOUS REPORTED EVENTS FOR THE VANGUARD HI-FLEX TRIAL RED TRAY 75MM (32-422204 LOT NO. ZB100902) AS A RESULT THERE IS NO CHANGE TO THE SEVERITY OR OCCURRENCE FOR THIS EVENT WITH THE REPORTED EVENT IS STILL CONSIDERED TO BE WITHIN THE SEVERITY OF THE RISK MANAGEMENT FILE.
IT WAS REPORTED THAT DURING THE PROCEDURE, AS THE SURGEON REMOVED THE TRIAL TRAY, THE PROTRUDING PART THAT HOOKS THE REMOVAL TOOL WAS FRACTURED INSIDE THE PATIENT BODY. THE FRACTURED PART WAS NOT ABLE TO BE REMOVED FROM THE PATIENT. THERE WAS NO DELAY OF THE PROCEDURE.
IT WAS REPORTED THAT DURING THE PROCEDURE, AS THE SURGEON REMOVED THE TRIAL TRAY, THE PROTRUDING PART THAT HOOKS THE REMOVAL TOOL WAS FRACTURED INSIDE THE PATIENT BODY. THE FRACTURED PART WAS NOT ABLE TO BE REMOVED FROM THE PATIENT. THERE WAS NO DELAY OF THE PROCEDURE.
(B)(4). OCCUPATION: QUALITY ASSURANCE. REPORT SOURCE: (B)(6). THE PRODUCT HAS BEEN RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.
IT WAS REPORTED THAT DURING THE PROCEDURE, AS THE SURGEON REMOVED THE TRIAL TRAY, THE PROTRUDING PART THAT HOOKS THE REMOVAL TOOL WAS FRACTURED INSIDE THE PATIENT BODY. THE FRACTURED PART WAS NOT ABLE TO BE REMOVED FROM THE PATIENT. THERE WAS NO DELAY OF THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 272696 | VNGD HIFLEX TRL RED TRAY 75MM | KNEE TIBIA TRIAL PROSTHESIS | JWH | BIOMET UK LTD. | N/A | ZB100902 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Other |