FIBERGRAFT BG PUTTY GPS 11CC
Report
- Report Number
- 1526439-2021-02577
- Event Type
- Malfunction
- Date Received
- December 16, 2021
- Date of Event
- November 17, 2021
- Report Date
- February 1, 2022
- Manufacturer
- PROSIDYAN, INC
- Product Code
- OAR
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- 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. B3. DATE OF EVENT. B4. DATE OF THIS REPORT. D1. BRAND NAME. D3. MANUFACTURER NAME AND ADDRESS. D4. CATALOG AND UNIQUE IDENTIFIER( UDI). H5. LABELED FOR SINGLE USE. H6 - CODES UPDATED TO IMDRF CODES. 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. FOLLOWING INVESTIGATION WAS PERFORMED BY THE SUPPLIER. ALTHOUGH DISTRIBUTED BY DEPUY SYNTHES TRAUMA, THE PRODUCT IS DESIGNED, MANUFACTURED, AND LABELED BY THE MANUFACTURING SUPPLIER. THE REQUIREMENT OF FDA REPORTING, COMPLAINT INVESTIGATION, ROOT CAUSE, AND CORRECTIVE ACTION IS THE RESPONSIBILITY OF THE DESIGNING SUPPLIER OF THIS ITEM, PER THE SUPPLIER AGREEMENT. THE PRODUCT/INFORMATION WILL BE TRANSFERRED TO THE SUPPLIER WITH THE COMPLAINT PROBLEM STATEMENT FOR INVESTIGATION. THE RESULTS OF THE SUPPLIER INVESTIGATION ARE TO BE POPULATED INTO THE DEPUY SYNTHES CUSTOMER QUALITY COMPLAINT MANAGEMENT SYSTEM. PER THE SUPPLIER AGREEMENT, THE SUPPLIER IS RESPONSIBLE FOR ANY CORRECTIVE ACTIONS IDENTIFIED DURING THE COMPLAINT INVESTIGATION PROCESS. AS PART OF DEPUY SYNTHES QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THE OVERALL COMPLAINT WAS CONFIRMED FOR THE FIBERGRAFT BG PUTTY GPS 11CC. BASED ON THE COMPLETED REVIEW WHICH INCLUDED DHR REVIEW, COMPLAINTS TRENDING, NONCONFORMANCE TRENDING, RISK ANALYSIS, ENGINEERING ANALYSIS, AND LABELING REVIEW, A DEFINITIVE CAUSE COULD NOT BE CONFIRMED, BUT THE POSSIBLE CAUSES WERE IDENTIFIED. THERE WAS ONE POTENTIALLY IDENTIFIED CAUSE REGARDING EXPOSURE OF THE PRODUCT TO HIGH TEMPERATURES. THIS FAILURE MODE HAS BEEN DETERMINED TO BE LOW RISK WITH A LOW FREQUENCY OF OCCURRENCE. ADDITIONALLY, MISUSE IS A POSSIBLE CAUSE AS THE COMPLAINT CONTACT COULD NOT CONFIRM WHETHER THE DEVICE WAS USED IN ACCORDANCE WITH THE IFU. THE FAILURES IN THIS COMPLAINT HAVE A LOW FREQUENCY OF OCCURRENCE AND WERE NOT DETERMINED TO BE SYSTEMIC. ALSO, THERE WAS NO IMPACT TO THE PATIENT AS A RESULT OF THIS COMPLAINT. SHOULD A SYSTEMIC ISSUE BE IDENTIFIED OR IF THE RISK PROFILE CHANGES DUE TO THIS FAILURE MODE, A CAPA WILL BE ISSUED PER CORRECTIVE AND PREVENTIVE ACTION. 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.
ADDITIONAL NARRATIVE: 510K: THIS REPORT IS FOR AN UNKNOWN PLUNGER/UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN. WITHOUT THE SPECIFIC PART NUMBER; THE UDI NUMBER AND 510-K NUMBER IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. INITIAL REPORTER IS A J&J SALES REPRESENTATIVE. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. 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.
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2021, DURING A PROCEDURE, A PEG LIQUID LEAK WAS OBSERVED AT PRODUCT OPENING. THE FIBERGRAFT PASTE INTO THE SYRINGE WAS VERY DENSE AND HARD TO PUSH OUT. CONSEQUENTLY THE PLUNGER BROKE AND ONE HAD TO TAKE THE GRAFT MANUALLY OUT OF THE SYRINGE BODY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY SURGICAL DELAY. THIS REPORT IS FOR ONE (1) UNKNOWN PLUNGER. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1913988 | FIBERGRAFT BG PUTTY GPS 11CC | INJECTOR, VERTEBROPLASTY | OAR | PROSIDYAN, INC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | UNK FIBERGRAFT PASTE| UNK PEG LIQUID |