4.5 HEALIX ADVANCE BR 3 SUTURE ANCHOR W/ ORTHOCORD
Report
- Report Number
- 1221934-2022-03467
- Event Type
- Malfunction
- Date Received
- November 10, 2022
- Date of Event
- October 17, 2022
- Manufacturer
- DEPUY MITEK LLC US
- Product Code
- MAI
- UDI-DI
- 10886705021321
- PMA / PMN Number
- K120078
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
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. ADDITIONAL NARRATIVE: UDI: (B)(4). REPORTER IS A J&J SALES REPRESENTATIVE. 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 MEDWATCH WILL BE FILED AS APPROPRIATE. : INVESTIGATION SUMMARY: THE COMPLAINT DEVICE IS NOT BEING RETURNED, THEREFORE UNAVAILABLE FOR A PHYSICAL EVALUATION. HOWEVER, A PHOTO OF AN X-RAY WAS PROVIDED. UPON VISUAL INSPECTION OF THE PHOTO, IT WAS OBSERVED THAT THE DEVICE IS SHOWN IMPLANTED IN THE BONE, HOWEVER, IT¿S NOT CLEAR TO SEE IF ANY METAL REMAINS IN THE PROXIMITY OF THE IMPLANT INSIDE THE PATIENT. THIS COMPLAINT CANNOT BE CONFIRMED. HANDS ON ANALYSIS SHOULD PROVIDE THE EVIDENCE NECESSARY TO CONFIRM THE ROOT CAUSE. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER: 9L27976, AND NO NONCONFORMANCES WERE IDENTIFIED. THE PHOTOS DO NOT PROVIDE ENOUGH EVIDENCE TO DETERMINE ROOT CAUSE. WITHOUT PHYSICAL EVALUATION OF THE DEVICES REPORTED, WE CANNOT ESTABLISH A ROOT CAUSE FOR THE ISSUE EXPERIENCED BY THE CUSTOMER. THE POSSIBLE ROOT CAUSE COULD BE RELATED TO PROCEDURAL VARIABLES, SUCH HANDLING OF THE DEVICE OR PRODUCT INTERACTION DURING PROCEDURE. HOWEVER, WE CANNOT CONCLUSIVE AFFIRMED. AT THIS POINT IN TIME, NO CORRECTIVE ACTION IS REQUIRED, AND NO FURTHER ACTION IS WARRANTED. HOWEVER, DEPUY SYNTHES MITEK WILL CONTINUE TO TRACK ANY RELATED COMPLAINTS WITHIN THIS DEVICE FAMILY AS A MEANS OF MONITORING THE EXTENT WITH WHICH THIS COMPLAINT IS OBSERVED IN THE FIELD.
IT WAS REPORTED BY THE SALES REP IN SOUTH KOREA THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6)2022 , IT WAS OBSERVED THAT THE TIP OF THE INSERTER ON THE 4.5 HEALIX ADVANCE BR 3 SUTURE ANCHOR W/ ORTHOCORD DEVICE WAS BROKEN UPON ITS REMOVAL AS THE DISTAL TIP OF INSERTER REMAINED IN THE BODY. ACCORDING TO THE REPORT, THE SURGEON NOTICED THE TIP ON POSTOPERATIVE X-RAY. 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 |
|---|---|---|---|---|---|---|---|
| 2877639 | 4.5 HEALIX ADVANCE BR 3 SUTURE ANCHOR W/ ORTHOCORD | SOFT-TISSUE ANCHOR, BIOABSORBABLE | MAI | DEPUY MITEK LLC US | 222296 | 9L27976 | 10886705021321 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Male |