TRIATHLON PS X3 TIBIAL INSERT
Report
- Report Number
- 0002249697-2023-01355
- Event Type
- Malfunction
- Date Received
- November 8, 2023
- Date of Event
- October 16, 2023
- Report Date
- January 29, 2024
- Manufacturer
- STRYKER ORTHOPAEDICS-MAHWAH
- Product Code
- MBH
- UDI-DI
- 07613327337907
- PMA / PMN Number
- K172634
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
REPORTED EVENT: AN EVENT REGARDING DAMAGE INVOLVING A TRIATHLON INSERT WAS REPORTED. THE EVENT WAS CONFIRMED VIA EVALUATION OF THE RETURNED DEVICE. METHOD & RESULTS: PRODUCT EVALUATION AND RESULTS: VISUAL INSPECTION: "THE DEVICE WAS FURTHER REVIEWED BY THE GLOBAL QUALITY & OPERATIONS (GQO) TEAM WHO INDICATED THE FOLLOWING: "THE ORIGINAL PACKAGING WAS NOT PROVIDED. REFERENCE IMAGES -THE DEVICE THAT WAS RETURNED HAD THE LOCKING WIRE IN PLACE. THE DEVICE HAD A GOUGE ON THE SIDE OF IT CONSISTENT WITH AN EXTREMELY SHARP CUTTING INSTRUMENT. THE DEVICES ARE 100% INSPECTED DURING THE TIBIAL PLASTICS AUTOMATION PER PROCEDURE, OJT FOR OPERATING THE CHIRON AUTOMATION CELL, THE DEPTH OF THE WIRE SLOT AND THE POSITION OF THE LOCKING WIRE WERE WITHIN SPECIFICATION. ADDITIONALLY, THE DEVICE WAS 100% INSPECTED THROUGHOUT THE FINAL PACKAGING PROCESS IN AN ISO CERTIFIED CLASS 8 CLEANROOM WHERE THE PER PROCEDURE FOR FINAL PACKAGING OF IMPLANTS AND STERILE INSTR. AS THE PART HAS A LARGE, SHARP GOUGE, THIS IS EASILY IDENTIFIABLE AND WOULD HAVE BEEN SCRAPPED PER THE PROCEDURE. FURTHERMORE, THE PACKAGING CELL DOES NOT CONTAIN ANY SHARP INSTRUMENTS, THEREFOR THE CREATION OF THE GOUGE DURING PROCESSING IS NOT POSSIBLE. BASED ON THE NATURE OF THE COMPLAINT, IT HAS BEEN DETERMINED THAT THE MANUFACTURING REQUIREMENTS, PER PROCEDURES HAVE BEEN MET. THE GLOBAL QUALITY AND OPERATIONS INVESTIGATION PROCESS IS UNABLE TO CONFIRM THAT THIS COMPLAINT IS A MANUFACTURING-RELATED ERROR. CONSEQUENTLY, A MANUFACTURING NON-CONFORMANCE WILL NOT BE OPENED." CLINICIAN REVIEW: NO MEDICAL RECORDS WERE RECEIVED FOR REVIEW WITH A CLINICAL CONSULTANT. PRODUCT HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO RELEVANT REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER SIMILAR EVENTS FOR THE LOT REFERENCED. CONCLUSIONS: IT WAS REPORTED THAT UPON OPENING THE PS INSERT, DAMAGE WAS IMMEDIATELY NOTED AT THE LOCKING MECHANISM, POSTERIOR ASPECT. VISUAL INSPECTION: "THE ORIGINAL PACKAGING WAS NOT PROVIDED. REFERENCE IMAGES -THE DEVICE THAT WAS RETURNED HAD THE LOCKING WIRE IN PLACE. THE DEVICE HAD A GOUGE ON THE SIDE OF IT CONSISTENT WITH AN EXTREMELY SHARP CUTTING INSTRUMENT. THE DEVICES ARE 100% INSPECTED DURING THE TIBIAL PLASTICS AUTOMATION PER PROCEDURE, OJT FOR OPERATING THE CHIRON AUTOMATION CELL, THE DEPTH OF THE WIRE SLOT AND THE POSITION OF THE LOCKING WIRE WERE WITHIN SPECIFICATION. ADDITIONALLY, THE DEVICE WAS 100% INSPECTED THROUGHOUT THE FINAL PACKAGING PROCESS IN AN ISO CERTIFIED CLASS 8 CLEANROOM WHERE THE PER PROCEDURE FOR FINAL PACKAGING OF IMPLANTS AND STERILE INSTR. AS THE PART HAS A LARGE, SHARP GOUGE, THIS IS EASILY IDENTIFIABLE AND WOULD HAVE BEEN SCRAPPED PER THE PROCEDURE. FURTHERMORE, THE PACKAGING CELL DOES NOT CONTAIN ANY SHARP INSTRUMENTS, THEREFOR THE CREATION OF THE GOUGE DURING PROCESSING IS NOT POSSIBLE. BASED ON THE NATURE OF THE COMPLAINT, IT HAS BEEN DETERMINED THAT THE MANUFACTURING REQUIREMENTS, PER PROCEDURES HAVE BEEN MET. THE GLOBAL QUALITY AND OPERATIONS INVESTIGATION PROCESS IS UNABLE TO CONFIRM THAT THIS COMPLAINT IS A MANUFACTURING-RELATED ERROR. CONSEQUENTLY, A MANUFACTURING NON-CONFORMANCE WILL NOT BE OPENED." NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE TO INDICATE FURTHER EVALUATION IS WARRANTED, THIS RECORD WILL BE REOPENED.
IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. REVIEW OF THE DEVICE HISTORY RECORDS INDICATE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO RELEVANT REPORTED DISCREPANCIES. THERE HAVE BEEN NO OTHER SIMILAR EVENTS FOR THE LOT REFERENCED. H3 OTHER TEXT : DEVICE NOT RETURNED TO THE MANUFACTURER
REVISION PROCEDURE, LEFT KNEE. IT WAS REPORTED THAT UPON OPENING THE PS INSERT, DAMAGE WAS IMMEDIATELY NOTED BY THE REP AT THE LOCKING MECHANISM, POSTERIOR ASPECT. A 2ND IMPLANT ALREADY IN THE OR WAS USED TO COMPLETE THE SURGERY SUCCESSFULLY WITH NO DELAY.
REVISION PROCEDURE, LEFT KNEE. IT WAS REPORTED THAT UPON OPENING THE PS INSERT, DAMAGE WAS IMMEDIATELY NOTED BY THE REP AT THE LOCKING MECHANISM, POSTERIOR ASPECT. A 2ND IMPLANT ALREADY IN THE OR WAS USED TO COMPLETE THE SURGERY SUCCESSFULLY WITH NO DELAY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1537109 | TRIATHLON PS X3 TIBIAL INSERT | PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO | MBH | STRYKER ORTHOPAEDICS-MAHWAH | T680R7 | 07613327337907 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Female | Other |