PSI 140*100*40 PEEK
Report
- Report Number
- 8030965-2023-09537
- Event Type
- Malfunction
- Date Received
- July 31, 2023
- Date of Event
- July 20, 2023
- Manufacturer
- SYNTHES GMBH
- Product Code
- GXN
- PMA / PMN Number
- K053199
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. B5: ADDITIONAL EVENT DESCRIPTION INFORMATION ADDED. E1: INITIAL REPORTER ADDRESS ADDED IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THIS MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. B3: DATE OF EVENT UPDATED D4: LOT # CORRECTED E1: INITIAL REPORTER NAME CORRECTED.
DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H3, H4, H6: PART NUMBER: SD800.435, LOT NUMBER: 6880P23, MANUFACTURING SITE: MEZZOVICO, RELEASE TO WAREHOUSE DATE: 30 JUN 2023. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE NOT STERILE FINISHED LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. THE PRODUCT WAS NOT RETURNED TO DEPUY SYNTHES FOR THIS DESIGN EVALUATION DOCUMENTATION. THE R&D TEAM CONDUCTED AN INVESTIGATION BASED OFF THE CASE RECORDS AND COMPLAINT DOCUMENTATION. PER THE COMPLAINT DESCRIPTION ABOVE, THE PSI CASE FILES AND COMMUNICATION WERE REVIEWED. THE INVESTIGATION INCLUDED AN END-TO-END PROCESS REVIEW OF THE DOCUMENTATION AND FORMS ALONG WITH THE SURGEON COMPLAINT REPORT AND THE RECEIVED DETAILS ON THE CASE. INCLUDING THE RECEIVED INTRA AND POST OPERATIVELY IMAGES. THE IMPLANT DESIGN WAS COMPLETED AND VERIFIED AS PER THE DEPUY SYNTHES DESIGN INSTRUCTIONS AND ROLES. AFTER THE SURGEON REVIEWED THE DESIGN AND APPROVED IT (WITH HIS SIGNATURE), THE DEVICE WAS PRODUCED AND INSPECTED ACCORDING TO PROCESS AND RELEASED UPON ACCEPTABLE QUALITY INSPECTION. BASED ON THE INFORMATION AND DOCUMENTS AVAILABLE, THIS DESIGN INVESTIGATION FOR THE DEVICE IS CLOSED AS NOT VALID REGARDING A DESIGN RELATED ROOT CAUSE. AS THE DEVICE WAS NOT RETURNED, AN AS-RECEIVED CONDITION COULD NOT BE ASSESSED, AND A DIMENSIONAL INSPECTION AND DOCUMENT/SPECIFICATION REVIEW WERE NOT COMPLETED. AS PART OF DEPUY SYNTHES QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THE OVERALL COMPLAINT WAS NOT CONFIRMED FOR THE PSI 140*100*40 PEEK. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE COMPLAINT CONDITION AND HENCE THE ROOT CAUSE CANNOT BE DETERMINED. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. 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.
DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. 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. B5: EVENT DESCRIPTION UPDATED.
DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H10 ADDITIONAL NARRATIVE: B3: ONLY EVENT YEAR IS KNOWN. D9: COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. E3: REPORTER IS A J&J EMPLOYEE. H3, H6: THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. 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.
NO FRAGMENTS WERE GENERATED. THE PROCEDURE WAS NOT COMPLETED SUCCESSFULLY.
THE PROCEDURE WAS DONE.
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN SWITZERLAND AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE COSMETIC RESULT IS NOT SATISFYING AND ITS POST-OP DAY 1 SO THE INDENT WILL BE EVEN MORE VISIBLE IN A FEW WEEKS. INTRA-OPERATIVELY THERE WAS A STEP BETWEEN PEEK AND BONE. IN THE PAST IT WAS REQUESTED TO TAKE THE PLASTIC ALL THE WAY DOWN AND ADD A MUSCLE COMPENSATION. IT IS THE FIRST TIME THE RESULT IS DISAPPOINTING. THIS REPORT INVOLVES ONE (1) PSI 140*100*40 PEEK. THIS IS REPORT 1 OF 1 FOR (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1908779 | PSI 140*100*40 PEEK | PLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE | GXN | SYNTHES GMBH | 6880P23 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Female | UNK - SCREWS: TRAUMA |