VNGD HIFLEX TRL RED TRAY 75MM 75MM
Report
- Report Number
- 3002806535-2019-00635
- Event Type
- Injury
- Date Received
- July 31, 2019
- Date of Event
- July 17, 2019
- Report Date
- May 22, 2020
- Manufacturer
- BIOMET UK LTD.
- Product Code
- LXH
- PMA / PMN Number
- N/A
- Removal / Correction Number
- N/A
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
(B)(4). THIS FINAL REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. G3: REPORT SOURCE, FOREIGN - EVENT OCCURRED IN JAPAN. PRODUCTS HAVE BEEN RETURNED TO BIOMET UK LTD FOR EVALUATION AND FORWARDED TO THE COMPLAINTS PROCESSING UNIT FOR INVESTIGATION. THE EVENT REPORTS THAT DURING THE PROCEDURE, AS THE SURGEON REMOVED THE TRIAL TRAY, THE PROTRUDING PART THAT HOOKS THE REMOVAL TOOL WAS CRACKED. THE FRACTURED PIECES FELL IN THE PATIENT. SOME PIECES WERE RETRIEVED FROM THE PATIENT BUT NOT ALL. THE FRACTURE / DAMAGE REPORTED ON THE LOCATING POST OF THE TRIAL REDUCER TRAY IS CONFIRMED. VISUAL INSPECTED THE RETURNED PRODUCT 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 14 YEARS. THE TRIAL REDUCER TRAY WAS MANUFACTURED BY EUROCUT SOMETIME IN 2006 (INDICATED BY THE START OF THE LOT # BEING E6). A MEMO FROM ORCHID ORTHOPEDIC SOLUTIONS SHEFFIELD LTD CONFIRMS THAT MANUFACTURING RECORDS FROM EUROCUT ARE NOT AVAILABLE PRE MAY 2008. WITHOUT THE OPPORTUNITY TO REVIEW MANUFACTURING RECORDS THE LIKELY CONDITION OF THE PART WHEN IT LEFT ZIMMER BIOMET CONTROL CANNOT BE DETERMINED. HOWEVER, AS THE ITEM HAS BEEN IN THE FIELD FOR SOME 14 YEARS IT IS LIKELY THAT IT WAS CONFORMING WHEN IT LEFT ZIMMER BIOMET CONTROL. 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 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 (219.3-GLBL-EN-REV0419), 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. RISK ASSESSMENT: A. THE SEVERITY ASSOCIATED WITH THE ABOVE LINES IS S-3, DEFINED, AS PER THE SEVERITY TABLE WITHIN UKP003 AS MODERATE - PRESCRIBED MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT OF A BODY FUNCTION OR BODY STRUCTURE. CONTRIBUTED TO MINOR, TEMPORARY, OR MEDICALLY REVERSIBLE INJURY. B. IT HAS BEEN REPORTED IN THE COMPLAINT THAT A DELAY OF 0-15 MINUTES WAS REQUIRED TO REMOVE FRAGMENTS FROM THE PATIENT. AT THIS POINT, NO FURTHER HARM HAS BEEN REPORTED AS A RESULT OF NOT ALL FRAGMENTS BEING REMOVED FROM THE PATIENT AND AS SUCH, WITH ASSESSMENT AGAINST EACH LINE DOCUMENTED ABOVE, THE SEVERITY IS CONSIDERED IN LINE WITH THE RMF. IF FURTHER INFORMATION IS SUPPLIED REGARDING THIS ISSUE, RE-ASSESSMENT CAN BE CONDUCTED. OCCURRENCE RATE ASSESSMENT: REQUIREMENT FOR OCCURRENCE RATE ASSESSMENT HAS NOT BEEN MET FOR THIS REPORTED EVENT. CORRECTIVE ACTION TAKEN: NO CORRECTIVE ACTION REQUIRED AT THIS TIME. PREVENTIVE ACTION TAKEN: NO PREVENTIVE ACTION REQUIRED AT THIS TIME. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
(B)(4). MANUFACTURING HISTORY RECORDS COULD NOT BE PERFORMED AS WE DO NOT HOLD ANY DHR FILES FOR PRODUCTS MANUFACTURED BY EUROCUT. THE FILES HAVE BEEN PREVIOUSLY REQUESTED, HOWEVER THEY ARE UNAVAILABLE. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
IT WAS REPORTED BY THE HOSPITAL THAT DURING AN OPERATION PERFORMED WITH VG PSRP, AS THE SURGEON REMOVED THE TRIAL TRAY, THE PROTRUDING PART THAT HOOKS THE REMOVAL TOOL WAS CRACKED. SUBSEQUENTLY, THE FRACTURED PIECES FELL IN THE PATIENT. SOME PIECES WERE RETRIEVED FROM THE PATIENT BUT NOT ALL.
IT WAS REPORTED BY THE HOSPITAL THAT DURING AN OPERATION PERFORMED WITH VG PSRP, AS THE SURGEON REMOVED THE TRIAL TRAY, THE PROTRUDING PART THAT HOOKS THE REMOVAL TOOL WAS CRACKED. SUBSEQUENTLY, THE FRACTURED PIECES FELL IN THE PATIENT. SOME PIECES WERE RETRIEVED FROM THE PATIENT BUT NOT ALL.
(B)(4). REPORT SOURCE, FOREIGN - EVENT OCCURRED IN (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN THE PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION IS COMPLETE, A SUPPLEMENTAL MDR WILL BE SUBMITTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION IS COMPLETE, A FOLLOW-UP MDR WILL BE SUBMITTED.
IT WAS REPORTED BY THE HOSPITAL THAT DURING AN OPERATION PERFORMED WITH VG PSRP, AS THE SURGEON REMOVED THE TRIAL TRAY, THE PROTRUDING PART THAT HOOKS THE REMOVAL TOOL WAS CRACKED. SUBSEQUENTLY, THE FRACTURED PIECES FELL IN THE PATIENT. SOME PIECES WERE RETRIEVED FROM THE PATIENT BUT NOT ALL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 638409 | VNGD HIFLEX TRL RED TRAY 75MM 75MM | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | LXH | BIOMET UK LTD. | N/A | E6 26030 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |