TIBIAL NAIL-ADVANCED / 10MM 360MM / STERILE
Report
- Report Number
- 8030965-2022-10909
- Event Type
- Malfunction
- Date Received
- December 12, 2022
- Date of Event
- November 5, 2022
- Manufacturer
- SYNTHES GMBH
- Product Code
- JDS
- UDI-DI
- 07612334171535
- PMA / PMN Number
- K201336
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- 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. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT AND NO NON-CONFORMANCE WAS IDENTIFIED. PRODUCT CODE: 04.043.240S. LOT #: 303P589. MANUFACTURING SITE: JABIL BETTLACH. RELEASE TO WAREHOUSE DATE: 07/09/2021. EXPIRY DATE: 01/08/2031. THE PRODUCT WAS RETURNED TO DEPUY SYNTHES FOR EVALUATION. THE DEPUY SYNTHES TEAM CONDUCTED A VISUAL INSPECTION OF THE RETURNED DEVICE. ADDITIONALLY, A VISUAL INSPECTION OF THE RETURNED DEVICE WAS PERFORMED FROM RETURNED PHOTOS. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT THE TIBIAL NAIL ADVANCED Ø10 L360 WAS FOUND THE INNER POLYMER BROKEN. THE BROKEN FRAGMENTS WERE RETURNED. THE PHOTO SHOWS A LARGE PIECE OF BONE FRAGMENT AS WELL - MOST LIKELY THIS IS CANCELLOUS BONE THAT WAS PUSHED INTO THE DISTAL OPENING OF THE NAIL AND MOVED THE INLAY IN THE NAIL PROXIMALLY. THIS IS COMPATIBLE WITH DIFFICULT NAIL INSERTION, THUS THE COMPLAINT IS CONFIRMED. IT IS POSSIBLE THAT THE INTRAMEDULLARY CANAL WAS NOT COMPLETELY REAMED TO THE INTENDED FINAL POSITION OF THE DISTAL NAIL TIP, THEREFORE DURING INSERTION OF THE NAIL, CANCELLOUS BONE WAS COMPACTED IN THE TIP OF THE NAIL, PUSHING THE INLAY PROXIMALLY. THIS COULD THEN INTERFERE WITH REMOVAL OF THE REAMING ROD. A DIMENSIONAL INSPECTION FOR THE TIBIAL NAIL ADVANCED Ø10 L360 WAS UNABLE TO BE PERFORMED DUE TO POST MANUFACTURING DAMAGE AND INACCESSIBILITY OF RELEVANT COMPONENTS. AS PART OF DEPUY SYNTHES QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE TIBIAL NAIL ADVANCED Ø10 L360 WOULD CONTRIBUTE TO THE COMPLAINED DEVICE ISSUE. 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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THIS MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. H4: DEVICE MANUFACTURE DATE 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. ADDITIONAL NARRATIVE: ADDITIONAL PRODUCT CODE: HWC. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION BUT HAS YET TO BE RECEIVED. POSTAL CODE-(B)(4). 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.
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. 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.
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED ON (B)(6)2022 , THAT THE NAIL WAS ADVANCED INTO THE TIBIA, WHEN IT BECAME INCREASINGLY DIFFICULT TO ADVANCE FURTHER. ON REMOVAL AND INSPECTION OF THE NAIL, CORTICAL BONE WAS FOUND TO HAVE BECOME LODGED IN THE DISTAL END OF THE NAIL. ON EXTRACTION OF THE CORTICAL BONE, PARTS OF THE POLYMER WERE DAMAGED AND RETRIEVED. THIS RESULTED IN A NEW NAIL BEING INSERTED. CONSEQUENTLY THERE WAS A DELAY IN OPERATIVE TIME. SURGEON COMMENT : ¿THERE WAS NO PROBLEM ADVANCING THE NAIL ¿ IT WAS ON TRYING TO REMOVE THE OLIVE TIPPED GUIDE WIRE WE RAN INTO TROUBLE AND THAT SOUNDS SIMILAR TO THE PROBLEM ENCOUNTERED A COUPLE OF DAYS EARLIER HERE IN STOKE. WE HAD TO REMOVE THE NAIL WITH THE GUIDE WIRE ATTACHED IN THE END AND FOUND THE WIRE JAMMED WITH A SMALL FRAGMENT OF CORTICAL BONE AT THE TIP AND THE PEEK INSERT WAS FRAGMENTING AND HAD MIGRATED PROXIMALLY BY ABOUT A CENTIMETRE FROM ITS ORIGINAL POSITION (HOLES NO LONGER LINED UP OR VISIBLE). CO-WORKER AND I HAVE ENCOUNTERED THIS BEFORE WITH THE EXPERT NAIL BUT I THINK THERE MAY BE TWO ISSUES WITH THIS ADVANCED NAIL; 1) THIS IS MORE LIKELY TO OCCUR BECAUSE THE APERTURE IS SMALLER BECAUSE OF THE PEEK INSERT (SO EASIER TO JAM BECAUSE WIRE IS A TIGHTER FIT), 2) IF THE PEEK INSERT IS BENT AND BROKEN THEN THE NAIL CANNOT BE SALVAGED TO INSERT OVER THE GUIDE WIRE BECAUSE THE BENT PROXIMALLY ADVANCED SLEEVE WILL PERSISTENTLY CAUSE AN OBSTRUCTION TO WIRE REMOVAL, UNLESS THERE IS AN EASY WAY TO REMOVE THE PEEK SLEEVE AND JUST USE THE STANDARD LOCKING HOLES AS USUAL¿. THIS REPORT IS FOR ONE (1) TIBIAL NAIL ADVANCED Ø10 L360 THIS IS REPORT 1 OF 1 FOR COMPLAINT PC-(B)(4).
THIS IS REPORT 1 OF 2 FOR (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 423997 | TIBIAL NAIL-ADVANCED / 10MM 360MM / STERILE | NAIL, FIXATION, BONE | JDS | SYNTHES GMBH | 303P589 | 07612334171535 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | UNK - GUIDE/COMPRESSION/K-WIRES |