SMARTSETGMV ENDURANCE GENT 40G
Report
- Report Number
- 1818910-2023-15456
- Event Type
- Malfunction
- Date Received
- July 28, 2023
- Date of Event
- June 28, 2023
- Report Date
- July 28, 2023
- Manufacturer
- DEPUY IRELAND - 9616671
- Product Code
- LOD
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
PRODUCT COMPLAINT # ==> (B)(4). INVESTIGATION SUMMARY ==> DURING PROCESS OF MATERIAL SEPARATION, THE COLLABORATOR FELT A "STRONG SMELL" ON THE PRODUCT *(PRODUCT DATA REMOVED). THE PRODUCT WAS INSPECTED AND OPENED BY THE QUALITY TEAM, WHICH FOUND AN INTERNAL COMPONENT (VIAL) BROKEN. THE DEVICE ASSOCIATED WITH THIS REPORT WAS RETURNED TO DEPUY SYNTHES FOR EVALUATION. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT THE PACKAGING BOX OF THE SMARTSETGMV ENDURANCE GENT 40G WAS OBSERVED IN OPENED CONDITION, THE AMPOULE WAS FOUND BROKEN AND THE PACKAGING DAMAGED AND WITH DRIED LIQUID LEAKED. THE REPORTED CONDITION WAS CONFIRMED. BASED ON THE PHYSICAL INVESTIGATION THE POTENTIAL CAUSE OF THE COMPLAINT CONDITION CANNOT BE DETERMINED OR TRACED TO A MANUFACTURING FACILITY. ONCE THE PRODUCT LEAVES DEPUY SYNTHES CONTROL, IT IS UNKNOWN WHAT ENVIRONMENT CONDITIONS THE PACKAGED PRODUCTS ARE EXPOSED TO DURING THAT TIME. THEREFORE, THE SUSPECTED CAUSE IS TRACED TO TRANSPORT/STORAGE OUTSIDE OF DEPUY SYNTHES CONTROL. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE SMARTSETGMV ENDURANCE GENT 40G WOULD CONTRIBUTE TO THE REPORTED DEVICE ISSUE. BASED ON THE INVESTIGATION FINDINGS, POTENTIAL CAUSE CAN BE ATTRIBUTED TO TRANSPORT/STORAGE AND 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 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 LOT ==> PRODUCT DESCRIPTION: SMARTSETGMV ENDURANCE GENT 40G PRODUCT CODE: 3105040 LOT NUMBER: 3820087 1) QUANTITY MANUFACTURED: 2800 2) DATE OF MANUFACTURE: 2022-05-26 3) ANY ANOMALIES OR DEVIATIONS IDENTIFIED IN DHR: NONE 4) EXPIRY DATE: 2025-04-30 5) IFU REFERENCE: IFU-0630132 REV. B DEVICE HISTORY REVIEW ==> A MANUFACTURING RECORD EVALUATION (NC SEARCH) WAS PERFORMED FOR THE FINISHED DEVICE PRODUCT CODE: 3105040, LOT-3820087 AND NO NON-CONFORMANCES / MANUFACTURING IRREGULARITIES WERE IDENTIFIED H10 ADDITIONAL NARRATIVE: ADDED: D4, D9 AND H4 H3.
PRODUCT COMPLAINT # (B)(4). 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 INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. DMF# - 13704. TRADE NAME GENTAMICIN SULPHATE. ACTIVE INGREDIENT(S) GENTAMICIN SULPHATE. DOSAGE FORM - POWDER. STRENGTH 1.0G ACTIVE IN OUR CEMENTS.
IT WAS REPORTED THAT DURING THE PROCESS OF MATERIAL SEPARATION, THE COLLABORATOR FELT A "STRONG SMELL" ON THE PRODUCT. THE PRODUCT WAS INSPECTED AND OPENED BY THE QUALITY TEAM, WHICH FOUND AN INTERNAL COMPONENT (VIAL) BROKEN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1919914 | SMARTSETGMV ENDURANCE GENT 40G | BONE CEMENT : BONE CEMENT | LOD | DEPUY IRELAND - 9616671 | 3820087 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |