4.5 HEALIX ADVANCE BR W/OCORD
Report
- Report Number
- 1221934-2025-05007
- Event Type
- Malfunction
- Date Received
- December 30, 2025
- Date of Event
- December 11, 2025
- Report Date
- December 30, 2025
- Manufacturer
- DEPUY MITEK LLC US
- Product Code
- MAI
- UDI-DI
- 10886705021314
- PMA / PMN Number
- K120078
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES, 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 REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. H11 ADDITIONAL NARRATIVE: THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. HOWEVER, SINCE THE INVESTIGATION IS STILL ON-GOING, THE ASSIGNABLE ROOT CAUSE COULD NOT BE DETERMINED AT THIS TIME. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP REPORT WILL BE SUBMITTED ACCORDINGLY.
THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES, 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 REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. H11 ADDITIONAL NARRATIVE: THE PRODUCT WAS RETURNED TO DEPUY SYNTHES FOR EVALUATION. VISUAL INSPECTION OF THE RETURNED DEVICE SHOWED THE ANCHOR STILL ATTACHED TO THE INSERTER AND CRACKED AT THE DISTAL END. NO OTHER ANOMALIES WERE NOTED. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF 4.5 HEALIX ADVANCE BR W/OCORD WOULD HAVE CONTRIBUTED TO THE COMPLAINED DEVICE ISSUE. BASED ON THE INVESTIGATION FINDINGS, THE POSSIBLE ROOT CAUSE CAN BE ASSOCIATED WITH OFF AXIS INSERTION AND LEVERING DURING INSERTION. AS PER IFU-100191, 1) INSERTING THE AWL OR DRILL TO LESS THAN THE SPECIFIED DEPTH, AXIAL MISALIGNMENT OR LEVERING WITH THE ANCHOR UPON INSERTION MAY RESULT IN ANCHOR FRACTURE. 2) DO NOT APPLY A BENDING FORCE TO THE INSERTER. THIS CAN DAMAGE THE ANCHOR OR INSERTER TIP. 3) APPLY TENSION (NORMAL FORCE) ON SUTURE LENGTHS. EXCESSIVE FORCE MAY OVERLOAD THE ANCHOR OR SUTURE. PROPERLY HANDLING AND¿ATTENTION TO THE APPROVED USE OF THE DEVICE DIMINISHES THE RISK OF FAILURE. IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE REPORTED COMPLAINT CONDITION. AS PART OF DEPUY SYNTHES QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE HISTORY REVIEW: THERE WAS NO NON-CONFORMANCE REGARDING THIS LOT.
THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES, 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 REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. H11 ADDITIONAL NARRATIVE: THE PRODUCT WAS NOT RETURNED TO DEPUY SYNTHES, HOWEVER A PHOTO WAS PROVIDED FOR EVALUATION. VISUAL INSPECTION OF THE RETURNED PHOTO SHOWED THE ANCHOR STILL ATTACHED TO THE INSERTER AND BROKEN AT THE DISTAL END. NO OTHER ANOMALIES WERE NOTED. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF 4.5 HEALIX ADVANCE BR W/OCORD WOULD HAVE CONTRIBUTED TO THE COMPLAINED DEVICE ISSUE.¿ BASED ON THE INVESTIGATION FINDINGS, THE POTENTIAL CAUSE IS TRACED TO THE PROCEDURAL VARIABLES, SUCH HANDLING OF THE DEVICE OR PRODUCT INTERACTION DURING PROCEDURE. THE POSSIBLE ROOT CAUSE CAN BE ASSOCIATED WITH OFF AXIS INSERTION AND LEVERING DURING INSERTION. IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE REPORTED COMPLAINT CONDITION. AS PART OF DEPUY SYNTHES QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES.¿
IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGICAL PROCEDURE IT WAS OBSERVED THAT THE 4.5 HEALIX ADVANCE BR W/OCORD DEVICE ANCHOR BROKE OFF. ALL BROKEN PARTS WERE REMOVED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTS OF DELAY IN THE PROCEDURE REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 154797 | 4.5 HEALIX ADVANCE BR W/OCORD | FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE | MAI | DEPUY MITEK LLC US | 104HMH | 10886705021314 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |