OFFSET REAMER HANDLE
Report
- Report Number
- 3004976965-2023-00006
- Event Type
- Malfunction
- Date Received
- May 5, 2023
- Date of Event
- April 4, 2023
- Report Date
- December 13, 2023
- Manufacturer
- VIANT MEDICAL, LLC
- Product Code
- LXH
- UDI-DI
- 00840096400083
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- 003
Narratives
H2: THE COMPLAINT SAMPLE WAS RETURNED TO VIANT FOR EVALUATION AND THE REPORTED EVENT IS CONFIRMED. THE UNIVERSAL JOINT (UJ) OF THE DRIVE CHAIN ARE SIGNIFICANTLY WORN CAUSING THE REPORTED "EXTRA MOVEMENT/PLAY" DUE TO PRODUCT END OF LIFE. THE ORIGINAL EVALUATION PERFORMED FOR THE INVESTIGATION WAS BASED ON IMAGES PROVIDED BY THE CUSTOMER. HOWEVER THE ALLEGED MALFUNCTION WAS UNABLE TO BE VERIFIED BASED ON THE PROVIDED IMAGES. THE COMPLAINT SAMPLE WAS THEN RETURNED 250 DAYS AFTER VIANT WAS MADE AWARE OF THE COMPLAINT FROM THE CUSTOMER. THE DEVICE WAS RETURNED TO VIANT DISASSEMBLED. EACH OF THE SUBASSEMBLIES THAT COMPRISE OF THE OFFSET REAMER HANDLE WAS VISUALLY INSPECTED AND THEN ASSEMBLED FOR FUNCTIONAL TESTING. WHEN ASSEMBLED, THE REPORTED EVENT WAS ABLE TO BE VERIFIED WHEN TURNING THE DRIVE CHAIN POWER ADAPTOR BY HAND. WHEN INITIATING ROTATION BY HAND ON THE POWER ADAPTOR END, THE REAMER HEAD END WOULD NOT ROTATE UNTIL THE UNIVERSAL JOINTS (UJ) MADE CONTACT. THIS WAS DUE TO THE SIGNIFICANT AMOUNT OF WEAR FOUND ON THE UJ AS THE DRIVE CHAIN HAS MET THE END OF ITS USEFUL LIFE. IN ADDITION, IT IS EVIDENT THAT THE DEVICE HAS BEEN MISUSED AS THE RETURNED ASSEMBLY IS MIXED FROM COMPONENTS FROM ANOTHER REAMER HANDLE. THIS DEVICE IS NOT INTENDED TO BE MIXED WITH COMPONENTS FROM ANOTHER DEVICE AND THEREFORE IS CONSIDERED MISUSE. THE RETURNED ASSEMBLY WAS COMPRISED OF THE BELOW MIXED COMPONENTS; · INDEX HANDLE, DRIVE CHAIN, Z-TUBE1: LOT "(B)(4).", AGED 8.51 YEARS · Z-TUBE2: LOT "(B)(4).", AGED 8.76 YEARS THE COMPONENTS OF EACH VIANT OFFSET REAMER HANDLE FORM A UNIQUE SET WHEN ASSEMBLED. IN NO INSTANCE SHOULD THE COMPONENTS FROM ONE REAMER HANDLE BE MIXED WITH COMPONENTS FROM ANOTHER DEVICE AS INSTRUCTED BY THE CURRENT IFUS MAN-004006 & MAN-004012. THE RETURNED OFFSET REAMER HANDLE ASSEMBLY HAD FAILED DUE TO NON-NORMAL USE CONDITIONS (USED BEYOND EXPECTED USEFUL LIFE AND UNINTENDED USE). OTHER OBSERVATIONS; · THE BLUE POM-C GRIP OF THE INDEX HANDLE WAS NOT RETURNED. · BOTH OF THE Z-TUBE COLLAR ENDS ARE SLIGHTLY BENT FROM IMPROPER DISASSEMBLY. · THE UNIVERSAL JOINTS (UJ) ARE WORN FROM REPEATED HEAVY USE AND THE NON-NORMAL USE CONDITIONS. · THE HUDSON POWER ADAPTER END IS WORN, DAMAGED, AND DEFORMED. THE DAMAGE AND DEFORMITY OBSERVED COULD HAD OCCURRED FROM A LOOSE CONNECTION BETWEEN THE ADJOINING ADAPTER/DRILL (NOT PROVIDED BY VIANT). · THE DEVICE WAS OBSERVED TO HAVE MANY SCRATCHES, NICKS, AND GOUGES. THE CURRENT IFU SENT WITH THIS DEVICE TODAY, MAN-004006 REV. A, STATES THE FOLLOWING; · END OF LIFE IS DETERMINED BY WEAR AND DAMAGE DUE TO INTENDED USE, · VISUALLY INSPECT FOR DAMAGE AND WEAR. IF THE INSTRUMENT IS DAMAGED AND WORN IT IS CONSIDERED AT THE END OF ITS LIFE AND SHOULD BE DISCARDED, · WHERE INSTRUMENTS FORM PART OF A LARGER ASSEMBLY, CHECK ASSEMBLY WITH MATING COMPONENTS, · CHECK HINGED INSTRUMENTS FOR SMOOTH MOVEMENT, · EACH COMPONENT OF THE VIANT OFFSET REAMER HANDLE IS NOT A MEDICAL DEVICE, ALL COMPONENTS WHEN ASSEMBLED CREATE THE MEDICAL DEVICE. THEREFORE, THE COMPONENTS OF EACH VIANT REAMER HANDLE FORM A UNIQUE SET WHEN ASSEMBLED. IN NO INSTANCE SHOULD THE COMPONENTS FROM ONE OFFSET REAMER HANDLE BE MIXED WITH COMPONENTS FROM ANOTHER REAMER HANDLE. THE UNIQUE DEVICE IDENTIFICATION FOR THIS MEDICAL DEVICE IS LOCATED ON THE ASSEMBLED OFFSET REAMER HANDLE, · VIANT DEVICES SHOULD ONLY BE USED BY QUALIFIED PERSONNEL FULLY TRAINED IN THE USE OF THE SURGICAL INSTRUMENTS AND THE RELEVANT SURGICAL PROCEDURES, · DO NOT MODIFY VIANT INSTRUMENTS IN ANY WAY AND HANDLE WITH CARE AT ALL TIMES. SURFACE SCRATCHES CAN INCREASE WEAR AND THE RISK OF CORROSION, · MANUAL SURGICAL INSTRUMENTS HAVE A LIMITED LIFE-SPAN WHICH IS DETERMINED BY WEAR OR DAMAGE DUE TO REPEATED INTENDED USE. WHEN A SURGICAL INSTRUMENT REACHES THE END OF ITS FUNCTIONAL LIFE, CLEAN THE INSTRUMENT OF ANY AND ALL BIOMATERIAL/BIOHAZARDS AND SAFELY DISCARD THE INSTRUMENT IN ACCORDANCE WITH APPLICABLE LAWS AND REGULATIONS. THE DEVICE HISTORY RECORDS (DHR) WERE REVIEWED AND FOUND NO RELATED MANUFACTURING DEVIATIONS OR ANOMALIES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE DRIVE CHAIN HAD EXPERIENCED APPROXIMATELY 8.51 YEARS OF USE. IT IS UNKNOWN AS TO HOW MANY SURGICAL PROCEDURES (CYCLES) THIS DEVICE HAD EXPERIENCED THROUGHOUT ITS LIFE IN THE FIELD. HOWEVER BASED ON THE AGE AND OBSERVATIONS, THE DRIVE CHAIN HAS BEEN USED BEYOND ITS EXPECTED USEFUL LIFE. THE VIANT RISK MANAGEMENT FILES WERE REVIEWED AND IDENTIFIED SIMILAR FAILURE MODES TO THE OBSERVED MALFUNCTION. FROM THE TREND ANALYSIS PERFORMED, THE ESTIMATED FAILURE RATE FALLS WITHIN THE OCCURRENCE RATE IDENTIFIED IN THE VIANT RISK MANAGEMENT FILES FOR THIS FAILURE MODE. IN CONCLUSION, THE REPORTED EVENT IS CONFIRMED AS THE RETURNED OFFSET REAMER HANDLE IS SIGNIFICANTLY WORN AT THE UNIVERSAL JOINTS OF THE DRIVE CHAIN, CAUSING THE REPORTED "EXTRA MOVEMENT/PLAY" DUE TO PRODUCT END OF LIFE. FROM THE INVESTIGATION PERFORMED, THE PRIMARY ROOT CAUSE IS ATTRIBUTED TO WEAR (USED BEYOND EXPECTED USEFUL LIFE). THE SECONDARY ROOT CAUSE COULD BE MISUSE AS THE RETURNED ASSEMBLY IS MIXED FROM COMPONENTS FROM ANOTHER REAMER HANDLE. THESE ARE CONSIDERED NON-NORMAL USE CONDITIONS. NO FURTHER INVESTIGATION WITH REGARD TO THIS COMPLAINT IS REQUIRED. VIANT WILL CONTINUE TO MONITOR FOR TRENDS.
THE COMPLAINT SAMPLE WAS NOT YET BEEN RETURNED TO VIANT FOR EVALUATION. THE CUSTOMER DID PROVIDE IMAGES OF THE OFFSET REAMER HANDLE, HOWEVER THE ALLEGED MALFUNCTION IS UNABLE TO BE VERIFIED BASED ON THE PROVIDED IMAGES. THE CUSTOMER PROVIDED 3 IMAGES OF THE OFFSET REAMER HANDLE. IMAGE 1 DEPICTS THE DISTAL END OF THE ASSEMBLED OFFSET REAMER HANDLE SHOWING ONLY FROM THE 30° TRANSITION TO THE REAMER HEAD. THE Z-TUBES & REAMER HEAD OF THE DRIVE CHAIN ARE SHOWN TO BE BLOODIED FROM USE AS REPORTED. NO CONCLUSIONS COULD BE DRAWN BASED ON THIS IMAGE. IMAGE 2 DEPICTS THE DISASSEMBLED OFFSET REAMER HANDLE SHOWING THE ONLY THE MIDDLE PORTIONS OF THE DRIVE CHAIN AND 2 BOTH Z-TUBES (1 FACING UP, 1 FACING DOWN). THE INDEX HANDLE IS NOT SHOWN. THE DRIVE CHAIN LOT NUMBER IS VISIBLE "PC2733417-49". DUE TO THE LIGHTING AND FOCUS OF THE IMAGE, THE LOT NUMBER OF THE Z-TUBE FACING UP COULD NOT BE READ. NO CONCLUSIONS COULD BE DRAWN BASED ON THIS IMAGE. IMAGE 3 DEPICTS THE DISASSEMBLED OFFSET REAMER HANDLE SHOWING ENTIRETY OF THE Z-TUBES (1 FACING UP, 1 FACING DOWN) AND THE DRIVE CHAIN (IMAGE IS CUT OFF AND NOW SHOWING THE HUDSON POWER ADAPTOR END). THE INDEX HANDLE IS NOT SHOWN. DUE TO THE LIGHTING AND FOCUS OF THE IMAGE, THE LOT NUMBER OF THE Z-TUBE FACING UP COULD NOT BE READ. HOWEVER, THE ENGRAVING OF THE Z-TUBE FACING DOWN IS VISIBLE "2756403-48". THIS Z-TUBE LOT WAS UTILIZED IN 4 FINISHED LOTS, 2 OF WHICH ARE FROM THE SAME PART NUMBER (T17653), OF WHICH 1 LOT IS FROM THE SAME LOT AS THE DRIVE CHAIN. ZOOMING IN ON THE IMAGE 3, IT'S EVIDENT THE PROXIMAL UNIVERSAL JOINT (UJ) ASSEMBLY (C4350) SHOW SIGNS OF WEAR ON THE FORKS (C3327). IT'S UNKNOWN IF THE DISTAL FORK (C3434) OR BLOCKS (C3329) ARE WORN DUE TO THE POSITION AND ANGLE OF THE IMAGE. BASED ON THE ABOVE, NO CONCLUSIONS COULD BE DRAWN BASED ON THE IMAGES PROVIDED TO VERIFY THE ALLEGED MALFUNCTION. THE CURRENT IFU SENT WITH THIS DEVICE TODAY, MAN-004006 REV. A, STATES THE FOLLOWING; END OF LIFE IS DETERMINED BY WEAR AND DAMAGE DUE TO INTENDED USE, VISUALLY INSPECT FOR DAMAGE AND WEAR. IF THE INSTRUMENT IS DAMAGED AND WORN IT IS CONSIDERED AT THE END OF ITS LIFE AND SHOULD BE DISCARDED, WHERE INSTRUMENTS FORM PART OF A LARGER ASSEMBLY, CHECK ASSEMBLY WITH MATING COMPONENTS, CHECK HINGED INSTRUMENTS FOR SMOOTH MOVEMENT, EACH COMPONENT OF THE VIANT OFFSET REAMER HANDLE IS NOT A MEDICAL DEVICE, ALL COMPONENTS WHEN ASSEMBLED CREATE THE MEDICAL DEVICE. THEREFORE, THE COMPONENTS OF EACH VIANT REAMER HANDLE FORM A UNIQUE SET WHEN ASSEMBLED. IN NO INSTANCE SHOULD THE COMPONENTS FROM ONE OFFSET REAMER HANDLE BE MIXED WITH COMPONENTS FROM ANOTHER REAMER HANDLE. THE UNIQUE DEVICE IDENTIFICATION FOR THIS MEDICAL DEVICE IS LOCATED ON THE ASSEMBLED OFFSET REAMER HANDLE, VIANT DEVICES SHOULD ONLY BE USED BY QUALIFIED PERSONNEL FULLY TRAINED IN THE USE OF THE SURGICAL INSTRUMENTS AND THE RELEVANT SURGICAL PROCEDURES, DO NOT MODIFY VIANT INSTRUMENTS IN ANY WAY AND HANDLE WITH CARE AT ALL TIMES. SURFACE SCRATCHES CAN INCREASE WEAR AND THE RISK OF CORROSION, MANUAL SURGICAL INSTRUMENTS HAVE A LIMITED LIFE-SPAN WHICH IS DETERMINED BY WEAR OR DAMAGE DUE TO REPEATED INTENDED USE. WHEN A SURGICAL INSTRUMENT REACHES THE END OF ITS FUNCTIONAL LIFE, CLEAN THE INSTRUMENT OF ANY AND ALL BIOMATERIAL/BIOHAZARDS AND SAFELY DISCARD THE INSTRUMENT IN ACCORDANCE WITH APPLICABLE LAWS AND REGULATIONS. THE DEVICE HISTORY RECORDS (DHR) WERE REVIEWED AND FOUND NO RELATED MANUFACTURING DEVIATIONS OR ANOMALIES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE DRIVE CHAIN HAD EXPERIENCED APPROXIMATELY 8.51 YEARS OF USE. IT IS UNKNOWN AS TO HOW MANY SURGICAL PROCEDURES (CYCLES) THIS DEVICE HAD EXPERIENCED THROUGHOUT ITS LIFE IN THE FIELD. THE CUSTOMER HAS INDICATED THE COMPLAINT SAMPLE WILL BE RETURNED TO VIANT FOR EVALUATION BUT HAS NOT BEEN RECEIVED TO DATE. ONCE THE COMPLAINT SAMPLE IS RECEIVED, IT WILL BE INVESTIGATED AND A FOLLOW-UP MEDWATCH 3500A EMDR WILL BE SUBMITTED ACCORDINGLY. G2: COMPLAINT INFORMATION PROVIDED BY DISTRIBUTOR, DEPUY SYNTHES. FOREIGN AS EVENT OCCURRED IN AUSTRALIA.
H2 ADDITIONAL INFORMATION: THE COMPLAINT SAMPLE WAS NOT RETURNED TO VIANT FOR EVALUATION. BASED ON THE AGE, THE DRIVE CHAIN WAS LIKELY USED BEYOND ITS EXPECTED USEFUL LIFE. IN CONCLUSION, VIANT IS UNABLE TO DRAW ANY CONCLUSIONS BASED ON THE IMAGES PROVIDED TO VERIFY THE ALLEGED MALFUNCTION. THUS, THE REPORTED EVENT IS NON-VERIFIABLE. IF THE COMPLAINT SAMPLE IS RECEIVED BY VIANT, IT WILL BE EVALUATED AND THE COMPLAINT RECORD WILL BE UPDATED ACCORDINGLY AND A SUPPLEMENTAL MEDWATCH 3500A EMDR WILL BE SUBMITTED AS WELL. NO FURTHER INVESTIGATION IS REQUIRED AT THIS TIME. H2, H6: UPDATED INVESTIGATION FINDINGS AND INVESTIGATION CONCLUSIONS BASED ON ADDITIONAL INFORMATION.
IT WAS REPORTED DURING ACETABULAR PREPARATION FOR A DIRECT ANTERIOR APPROACH (DAA) TOTAL HIP REPLACEMENT (THR) ON A FEMALE PATIENT THAT THE SURGEON NOTICED THERE WAS A LOT OF EXTRA MOVEMENT/PLAY IN THE DISTAL END OF THE OFFSET REAMER HANDLE. THE SURGEON CONTINUED TO USE THE HANDLE ON A LOW SPEED TO NOT AFFECT THE BONE-IMPLANT INTERFACE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO ADVERSE EVENTS NOR PATIENT CONSEQUENCE AS A RESULT OF THE MALFUNCTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 574645 | OFFSET REAMER HANDLE | REAMER HANDLE | LXH | VIANT MEDICAL, LLC | 255000100 | PC2733417 | 00840096400083 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female |