5.5MM HEALIX ADVANCE¿ PEEK ANCHOR WITH DYNACORD¿ SUT (BLU,WHT/BLU/GRN,WHT/BLK)
Report
- Report Number
- 1221934-2023-01565
- Event Type
- Malfunction
- Date Received
- April 11, 2023
- Date of Event
- March 22, 2023
- Manufacturer
- MEDOS INTERNATIONAL SARL
- Product Code
- MBI
- UDI-DI
- 10886705029488
- PMA / PMN Number
- K173859
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
THIS REPORT IS BEING SUBMITTED IN PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY MITEK OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY MITEK, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. UDI: (B)(4). E3: REPORTER IS A J&J EMPLOYEE. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT.
THIS REPORT IS BEING SUBMITTED IN PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY MITEK OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY MITEK, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEWATCH WILL BE FILED AS APPROPRIATE. H10 ADDITIONAL NARRATIVE: INVESTIGATION SUMMARY: A PHOTO WAS RETURNED TO DEPUY SYNTHES MITEK FOR EVALUATION. THE DEPUY SYNTHES MITEK TEAM CONDUCTED A VISUAL INSPECTION OF THE RETURNED PHOTO. THE DEVICE WAS DISCARDED, THEREFORE, UNAVAILABLE FOR A PHYSICAL EVALUATION. VISUAL ANALYSIS OF THE PHOTO REVEALED THAT THE FOIL POUCH IS DAMAGED A PARTIAL PART OF THE DESICCATING PAPER SHEATH IS SHOWN. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 9L40625 NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. AS PART OF DEPUY SYNTHES MITEK QUALITY PROCESS ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ACCORDING WITH THE VISUAL INSPECTION, THIS COMPLAINT CAN BE CONFIRMED. THE MANUFACTURER PERFORMED AN INVESTIGATION WITH THE FOLLOWING RESULTS:AN IN-PROCESS CONTROL HAS BEEN PERFORMED ON 9 PARTS CHOSEN RANDOMLY BY A CERTIFIED OPERATOR AND HAVE BEEN INSPECTED ALSO PER WI-FT 0118 REV27, THE PIC-VSE0028 REV:8 AND PIC-VSE0029 REV: 14 THE RESULT OF THIS PROCESS CHECK IS SUCCESSFUL, NONE OF THE 9 PARTS WERE NON-CONFORMED. SO, THERE IS NO NEED TO INSPECT MORE PARTS OF THE BATCH NOR RAISE A NON CONFORMANCE. THE BATCHS HAVE BEEN ASSEMBLED BY OPERATORS TRAINED AND CERTIFIED ON THE PROCESS VALIDATED IN PRODUCTION. A TRAINING VERIFICATION HAS BEEN PERFORMED AT THE MOMENT IN THE PRODUCTION WHERE THE ISSUE COULD HAVE OCCURRED. EVERY EMPLOYEE HAS COMPLETED THE TRAINING FOR THE PROCESSES. ACCORDING TO THE FAILURE MODES AND EFFECTS ANALYSIS PVA-120643-PFMEA REV: G. THE POTENTIAL OCCURRENCE OF AN ANCHOR FAILURE WAS EVALUATED AS 0. THE ANALYSIS SHOWED THAT THE PRODUCTION CONTROLS IMPLEMENTED AT THE STERILE AND NO STERILE LEVEL, AS WELL AS THE PROCESS CONTROLS GUARANTEE 100% DETECTION OF THIS TYPE OF PROBLEM IF IT WAS GENERATED IN NEUCHÂTEL. A 100% VISUAL CONTROL ON THE VISUAL ASPECT OF THE POUCH AND AN IN-PROCESS CONTROL OF 9 PIECES TAKEN RANDOMLY, GUARANTEE THAT THIS TYPE OF DEFECT DOES NOT OCCUR IN THE MANUFACTURING PROCESS, WE CAN CONCLUDE THAT IT IS HIGHLY UNLIKELY THAT THESE DEFECTS WERE GENERATED DURING THE MANUFACTURING PROCESS. A MANUFACTURING INVESTIGATION ACTIVITY WAS CONDUCTED TO DETERMINE IF THERE WERE ANY INTERNAL PROCESSING ISSUES THAT MAY HAVE CONTRIBUTED TO THE NATURE OF THE PRODUCT COMPLAINT. A THOROUGH REVIEW OF PRODUCTION PROCESS CONTROLS WAS CONDUCTED. THE RESULTS SHOW THAT THIS BATCH OF PRODUCT WAS PROCESSED WITHOUT INCIDENT. NEVERTHELESS, THERE IS NO EVIDENCE OF MANUFACTURING ANOMALIES. BASED ON THE ABOVE, IT IS CONFIRMED THAT THE MANUFACTURING PROCESS WAS PERFORMED IN ACCORDANCE WITH THE VALIDATED PROCESSES. THE ROOT CAUSE IS NOT RELATED TO MANUFACTURING. IF THE PACKING WAS DAMAGED, IT CANNOT BE RELATED TO A PROBLEM OCCURRING DURING THE MANUFACTURING PROCESS. THEREFORE IT COULD BE RELATED TO PROCEDURAL VARIABLES, SUCH HANDLING OF THE DEVICE OR PRODUCT INTERACTION BEFORE PROCEDURE, A MISHANDLING OF THE DEVICE WHILE IT WAS BEING UNPACKAGE CAN LEAD TO DAMAGES IN THE FOIL POUCH, HOWEVER THIS CANNOT BE CONCLUSIVELY DETERMINED, AT THIS POINT IN TIME, NO CORRECTIVE ACTION IS REQUIRED, AND NO FURTHER ACTION IS WARRANTED. HOWEVER, DEPUY SYNTHES MITEK WILL CONTINUE TO MONITOR ADDITIONAL COMPLAINT INFORMATION FOR POTENTIAL SAFETY SIGNALS THROUGH COMPLAINT TRENDING AS PART OF POST MARKET SURVEILLANCE.
IT WAS REPORTED BY THE AFFILIATE IN GERMANY THAT PREOPERATIVELY TO AN SHOULDER ARTHROSCOPY PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE 5.5MM HEALIX ADVANCE¿ PEEK ANCHOR WITH DYNACORD¿ SUTURE (BLUE, WHITE/BLUE/GREEN, WHITE/BLACK) WAS DELIVERED ¿NON-STERILE¿ IN A CARDBOARD BOX. ACCORDING TO THE REPORT, THE CARDBOARD OUTER PACKAGING WAS INTACT, BUT THE ALUMINUM FOIL AROUND THE HEALIX ANCHOR WAS OPEN OR NO LONGER STERILE SEALED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 402720 | 5.5MM HEALIX ADVANCE¿ PEEK ANCHOR WITH DYNACORD¿ SUT (BLU,WHT/BLU/GRN,WHT/BLK) | SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE | MBI | MEDOS INTERNATIONAL SARL | 222033 | 9L40625 | 10886705029488 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |