SFXSPI MCL+ UNI UD 18IN 3-0 SA PS PMP
Report
- Report Number
- 2210968-2024-07948
- Event Type
- Malfunction
- Date Received
- August 1, 2024
- Date of Event
- June 14, 2024
- Manufacturer
- ETHICON INC.
- Product Code
- GAM
- PMA / PMN Number
- N12159
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 9/10/2024. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803, PART 4 SUBPART B. 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 ETHICON, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, 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. H6 COMPONENT CODE: G07002 NO DEVICE PROBLEM FOUND A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED, AND NO RELATED NON-CONFORMANCES WERE IDENTIFIED. H3 INVESTIGATIONAL SUMMARY: THE PRODUCT WAS RETURNED TO ETHICON FOR EVALUATION. ONE NEEDLE-SUTURE PIECE WAS RECEIVED FOR ANALYSIS. PRODUCT CODE SXMP1B111. DURING THE VISUAL INSPECTION OF THE NEEDLE, THE SWAGE AND ATTACHMENT AREA WERE NOTED TO BE AS EXPECTED. THE RECEIVED SUTURE PIECE WAS INSPECTED, AND NO BREAKAGE SUTURE WAS OBSERVED. BUT THE EXTREME WAS NOTED TO BE BROKEN AND DAMAGED (CRUSHED) PROBABLY CAUSED BY A SURGICAL INSTRUMENT. THE OTHER SECTION OF THE SUTURE WAS NOT RETURNED FOR ANALYSIS. THE PRODUCT CODE SXMP1B111 CONTAINS AN ABSORBABLE SUTURE. SINCE THE SAMPLE WAS RECEIVED OPEN, THE FUNCTIONAL TEST COULD NOT BE PERFORMED DUE TO UNDETERMINED EXPOSURE TIME TO THE ENVIRONMENT. AS PART OF OUR QUALITY PROCESS, THE MANUFACTURING RECORDS OF THIS LOT-SERIAL NUMBER WERE REVIEWED, AND THE MANUFACTURING STANDARDS WERE MET PRIOR TO THE RELEASE OF THIS BATCH. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF POST-MARKET SURVEILLANCE.
(B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR PART 803, PART 4 SUBPART B. 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 ETHICON, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, 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. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. WERE THERE ANY PATIENT CONSEQUENCES? ATTEMPTS ARE BEING MADE TO RETRIEVE THE DEVICE. 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. H6 COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED.
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNSPECIFIED ORTHOPEDIC PROCEDURE ON (B)(6) 2024 AND BARBED SUTURE WAS USED. THE DEVICE BROKE AFTER GOING THROUGH TISSUE. A SECOND SUTURE WAS USED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1978431 | SFXSPI MCL+ UNI UD 18IN 3-0 SA PS PMP | SUTURE, SURGICAL, ABSORBABLE, POLYGLCOLIC ACID | GAM | ETHICON INC. | TKBHZE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |