SMARTSET GHV GENTAMICIN 40G
Report
- Report Number
- 1818910-2024-10197
- Event Type
- Malfunction
- Date Received
- May 8, 2024
- Date of Event
- March 3, 2024
- Report Date
- May 8, 2024
- Manufacturer
- DEPUY IRELAND - 3015516266
- Product Code
- MBB
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NZ
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: ACCORDING TO THE INFORMATION RECEIVED, "WHILE CEMENTING THE TIBIA AND FEMUR, SURGEON AND HIS ASSISTANT REPORTED THAT THE CEMENT HAD NOT MIXED VERY WELL. IT FELT TACKY EARLIER THAN USUAL AND WAS NOT AS SMOOTH TO USE." THE PRODUCT WAS NOT RETURNED TO DEPUY SYNTHES, HOWEVER PHOTOS WERE PROVIDED FOR REVIEW. PHOTOS WERE PROVIDED FOR REVIEW, HOWEVER THE PHOTOS ONLY SHOW PART AND LOT NUMBER AND NO OTHER OBSERVATION PERTAINING TO THE NATURE OF THE REPORTED EVENT COULD BE IDENTIFIED. THEREFORE, THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE REPORTED EVENT DUE TO THE INSUFFICIENT EVIDENCE PROVIDED. SINCE THE DEVICE WAS NOT RETURNED, A DIMENSIONAL INSPECTION CANNOT BE PERFORMED. THOUGH MANUFACTURING INVESTIGATION WAS PERFORMED. INVESTIGATION RESULT: LOT: 3980082. MANUFACTURING DATE: 31 OCT 22. EXPIRY DATE: 30 SEP 24. QUANTITY: (B)(4). THERE IS ONE NON-CONFORMANCE ASSOCIATED WITH THIS BATCH. ON REVIEW OF THE APPLICABLE NC IT HAS BEEN IDENTIFIED THAT THE NC WOULD NOT HAVE CONTRIBUTED TO THE COMPLAINT EVENT. THE SAMPLES RETURNED WERE TESTED IN A TEMPERATURE AND HUMIDITY-CONTROLLED LABORATORY (SEE PAGE 2). LOT: 3980082 DOUGH TIME: 54S (SPEC: 1 MIN 30S MAX). MIX CHARACTERISTICS: FIRM. SETTING TIME: 9 MIN 56S (SPEC: 08 MIN 30S TO 12 MIN 30S). THE CEMENT MIXED AND BEHAVED AS EXPECTED FOR THE PRODUCT TYPE AND MET THE APPROPRIATE CONTROL SPECIFICATION (MS-010 SMARTSET GHV GENTAMICIN BONE CEMENT). THE OVERALL COMPLAINT WAS UNCONFIRMED AS THE PHOTOGRAPHS PROVIDED CONTAINED INSUFFICIENT EVIDENCE OF THE REPORTED EVENT. BASED ON THE INVESTIGATION FINDINGS, 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: LOT: 3980082. MANUFACTURING DATE: 31 OCT 22. EXPIRY DATE: 30 SEP 24. QUANTITY: (B)(4). THERE IS ONE NON-CONFORMANCE ASSOCIATED WITH THIS BATCH. ON REVIEW OF THE APPLICABLE NC IT HAS BEEN IDENTIFIED THAT THE NC WOULD NOT HAVE CONTRIBUTED TO THE COMPLAINT EVENT. THE SAMPLES RETURNED WERE TESTED IN A TEMPERATURE AND HUMIDITY-CONTROLLED LABORATORY (SEE PAGE 2). LOT: 3980082. DOUGH TIME: 54S (SPEC: 1 MIN 30S MAX). MIX CHARACTERISTICS: FIRM. SETTING TIME: 9 MIN 56S (SPEC: 08 MIN 30S TO 12 MIN 30S). THE CEMENT MIXED AND BEHAVED AS EXPECTED FOR THE PRODUCT TYPE AND MET THE APPROPRIATE CONTROL SPECIFICATION (MS-010 SMARTSET GHV GENTAMICIN BONE CEMENT).
PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H10 ADDITIONAL NARRATIVE: ADDED: B5. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.
PRODUCT COMPLAINT # (B)(4). DMF# - 13704. TRADE NAME ¿ GENTAMICIN SULPHATE. ACTIVE INGREDIENT(S) ¿ GENTAMICIN SULPHATE. DOSAGE FORM ¿ POWDER. STRENGTH ¿ 1.0G ACTIVE IN OUR CEMENTS. G4: OUS SIMILAR DEVICE. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, 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 REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.
ADDITIONAL INFORMATION WAS RECEIVED: A. WHAT WAS THE STORAGE TEMPERATURE OF THE CEMENT PRIOR TO USAGE? - STORAGE TEMPERATURE WAS 18 DEGREES. B. WHAT WAS THE OR TEMPERATURE DURING USE OF THE CEMENT? - OT THEATRE WAS 19 DEGREES. C. HOW WAS THE CEMENT PREPARED FOR USE? -CEMENT WAS MIXED FOR 45 SECONDS IN A CEMENT GUN CONTAINER WITH VACUUM. D. WHAT WAS THE TIMING TO MIX AND THE TIME BETWEEN MIXING AND SETTING? - CEMENT SET AT 14 MINUTES HOWEVER IT WAS UNWORKABLE FROM 8MINUTES. E. WHAT EQUIPMENT WAS USED TO DELIVER THE CEMENT? - CEMENT GUN WAS USED TO DELIVER THE CEMENT.
DURING THE CASE, WHILE CEMENTING THE TIBIA AND FEMUR, SURGEON AND HIS ASSISTANT REPORTED THAT THE CEMENT HAD NOT MIXED VERY WELL. IT FELT TACKY EARLIER THAN USUAL AND WAS NOT AS SMOOTH TO USE. THE CEMENT WAS MIXED THE SAME WAY. UPON LOOKING INTO THE STORAGE OF THE CEMENT, THEY HAVE BEEN MOVED TO ANOTHER ROOM IN THE HOSPITAL WHICH IS SET AT A COLDER ROOM TEMPERATURE OF 18 DEGREES. THE THEATRE TEMPERATURE WAS 19 DEGREES DURING THE OPERATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 753856 | SMARTSET GHV GENTAMICIN 40G | BONE CEMENT : BONE CEMENT | MBB | DEPUY IRELAND - 3015516266 | 3980082 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |