LUPINE LOOP RAPIDE ANCHOR W/ORTHOCORD DS
Report
- Report Number
- 1221934-2022-04043
- Event Type
- Malfunction
- Date Received
- December 19, 2022
- Manufacturer
- DEPUY MITEK LLC US
- Product Code
- MAI
- UDI-DI
- 10886705001101
- PMA / PMN Number
- K150209
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TH
- 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 MITEK OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, 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. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. H10 ADDITIONAL NARRATIVE: D9, H3, H6: THE ACTUAL DEVICE HAS BEEN RETURNED AND IS CURRENTLY PENDING EVALUATION. ONCE THE DEVICE HAS BEEN EVALUATED, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT ACCORDINGLY.
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 MITEK OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, 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. E1: SUBSEQUENT FOLLOW-UP WITH THE CUSTOMER, ADDITIONAL INFORMATION WAS RECEIVED REGARDING THE USER FACILITY. THEREFORE, THE INITIAL REPORTER FACILITY NAME AND ADDRESS HAVE BEEN UPDATED ACCORDINGLY.
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). 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. H10 ADDITIONAL NARRATIVE: INVESTIGATION SUMMARY ==> THE DEVICE WAS RETURNED TO MITEK FOR EVALUATION. MITEK THEN CONDUCTED VISUAL INSPECTION OF DEVICE RECEIVED. UPON VISUAL INSPECTION OF THE DEVICE, IT WAS OBSERVED THAT THE ANCHOR WAS BENT NEAR MID-BODY, CONFIRMING THIS COMPLAINT. THE ANCHOR REMAINED INTACT ON THE DISTAL END OF THE INSERTER AND THE SUTURE WAS INTACT WITHIN THE HANDLE AT THE PROXIMAL END OF THE INSERTER AS INTENDED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER: 9L11060, AND NO NONCONFORMANCES WERE IDENTIFIED. THIS PRODUCT HAS A 100% CONTROL AT DIFFERENT STAGES OF MANUFACTURING LINE: ANCHOR TIGHTENING, BY A TORQUE METER + ANCHOR/SHAFT ASSEMBLY + ANCHOR/SHAFT GAP WITH A MEASURING GAUGE. ALSO, 100% VISUAL CONTROL: CHECK THAT NO DEGRADATION ON THE SUTURE AND ON THE ANCHOR IS PRESENT. THIS TYPE OF DEFECT IN LUPINE ANCHORS HAS BEEN REVIEWED. THE SAMPLE WAS CHARACTERIZED BY SCANNING ELECTRON MICROSCOPE (SEM); AS A RESULT, THE IMAGES SHOW EVIDENCE OF PLASTIC DEFORMATION. WHEN POLYLACTIC ACID (PLA), THE COMPONENT OF THIS DEVICE, IS EXPOSED TO TEMPERATURES OVER 21 DEGREES C, ITS STRUCTURE GETS COMPROMISED AS IT TENTS TO LOSE MASS, IT PROVIDES FLEXIBILITY TO THE POLYMER CHAINS PRODUCING A DECREASE IN THE DEGREE OF CRYSTALLINITY OF THE STRUCTURE AND THE MICROHARDNESS VALUES CAUSING THESE TYPES OF DEFORMATIONS (ZULUAGA, 2013). THESE DAMAGES HAVE TYPICAL CHARACTERISTICS OF MATERIAL EXPOSED TO HIGH TEMPERATURES; HOWEVER, THIS CANNOT BE CONCLUSIVELY DETERMINED. PLEASE SEE THE ATTACHMENT ISR-2023-8264. BASED ON THE RESULTS, THE PROBABLE ROOT CAUSE OF THIS FAILURE IS THAT THE DEVICES WERE EXPOSED TO AN ELEVATED TEMPERATURE BEFORE IT WAS OPENED IN THE OPERATING ROOM PRIOR TO SURGERY. THE ELEVATED TEMPERATURE AND THE SLIGHT TENSION ON THE SUTURE COULD RESULT IN THE BENDING OF THE ANCHOR. NO FURTHER INFORMATION REGARDING THE CAUSE OF THE DEFECT HAS BEEN PROVIDED TO HELP DETERMINE A ROOT CAUSE FOR THIS FAILURE. AS PER IFU, STORE IN A COOL DRY PLACE. AS PART OF MITEK¿S QUALITY PROCESS ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. AT THIS POINT IN TIME, NO CORRECTIVE ACTION IS REQUIRED, AND NO FURTHER ACTION IS WARRANTED. HOWEVER, IN DEPUY SYNTHES MITEK, ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS IS CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF POST MARKET SURVEILLANCE.
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 FOLLW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. H10 ADDITIONAL NARRATIVE: INVESTIGATION SUMMARY ==> THE COMPLAINT DEVICE HAS NOT RETURNED, THEREFORE UNAVAILABLE FOR A PHYSICAL EVALUATION. HOWEVER, A PHOTO WAS PROVIDED. UPON VISUAL INSPECTION OF THE PHOTO, IT WAS OBSERVED THAT THE ANCHOR WAS BENT NEAR MID-BODY, CONFIRMING THIS COMPLAINT. THE ANCHOR APPEARED INTACT ON THE DISTAL END OF THE INSERTER AND THE SUTURE WAS INTACT WITHIN THE HANDLE AT THE PROXIMAL END OF THE INSERTER AS INTENDED. THIS COMPLAINT CAN BE CONFIRMED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER: 9L11060, AND NO NONCONFORMANCES WERE IDENTIFIED. THE PHOTO DOES NOT PROVIDE ENOUGH EVIDENCE TO DETERMINE ROOT CAUSE. PHYSICAL EVALUATION SHOULD PROVIDE MORE INFORMATION TO DISCERN A POSSIBLE ROOT CAUSE. WHEN POLYLACTIC ACID (PLAY), THE COMPONENT OF THIS DEVICE IS EXPOSED TO HIGH TEMPERATURES, ITS STRUCTURE GETS COMPROMISED AS IT TENTS TO LOSE MASS, IT PROVIDES FLEXIBILITY TO THE POLYMER CHAINS PRODUCING A DECREASE IN THE DEGREE OF CRYSTALLINITY OF THE STRUCTURE AND THE MICROHARDNESS VALUES CAUSING THESE TYPES OF DEFORMATIONS. THESE DAMAGES HAVE TYPICAL CHARACTERISTICS OF MATERIAL EXPOSED TO TEMPERATURES HIGHER, HOWEVER THIS CANNOT BE CONCLUSIVELY DETERMINED. THE POSSIBLE ROOT CAUSE OF THIS FAILURE IS THAT THE DEVICES WERE EXPOSED TO AN ELEVATED TEMPERATURE BEFORE IT WAS OPENED IN THE OPERATING ROOM PRIOR TO SURGERY. THE ELEVATED TEMPERATURE AND THE SLIGHT TENSION ON THE SUTURE COULD RESULT IN THE BENDING OF THE ANCHOR. NO FURTHER INFORMATION REGARDING THE CAUSE OF THE DEFECT HAS BEEN PROVIDED TO HELP DETERMINE A ROOT CAUSE FOR THIS FAILURE. AS PER IFU: STORE IN A COOL DRY PLACE. 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 THAILAND DURING AN UNKNOWN SURGERY ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE LUPINE LOOP RAPIDE ANCHOR W/ORTHOCORD DS DEVICE WAS BENT AND OUT OF SHAPE. 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 |
|---|---|---|---|---|---|---|---|
| 1867791 | LUPINE LOOP RAPIDE ANCHOR W/ORTHOCORD DS | SOFT-TISSUE ANCHOR, BIOABSORBABLE | MAI | DEPUY MITEK LLC US | 210712 | 9L11060 | 10886705001101 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |