TIBIAL NAIL ADVANCED Ø10 L315
Report
- Report Number
- 8030965-2023-07314
- Event Type
- Malfunction
- Date Received
- June 8, 2023
- Date of Event
- May 24, 2023
- Manufacturer
- SYNTHES GMBH
- Product Code
- JDS
- UDI-DI
- 07612334171504
- PMA / PMN Number
- K201336
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- 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. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE PRODUCT CODE#:04.043.225S. LOT #:1919P89. IT WAS ELECTRONICALLY REVIEWED AND NO NONCONFORMANCES / MANUFACTURING IRREGULARITIES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS. THE PRODUCT WAS RELEASED ON: 26/11/2022. MANUFACTURING SITE: JABIL BETTLACH. EXPIRY DATE:01/09/2032. THE PRODUCT WAS RETURNED TO DEPUY SYNTHES FOR EVALUATION. THE DEPUY SYNTHES TEAM CONDUCTED A VISUAL INSPECTION OF THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT TIBIAL NAIL ADVANCED Ø10 L315 WAS FOUND THE DEVICE STUCK IN THE MATING DEVICE [SYNREAM REAMING ROD ø2.5]. THE ALLEGATION CAN BE CONFIRMED. NO OTHER DEFECT WAS FOUND. A DIMENSIONAL INSPECTION FOR THE TIBIAL NAIL ADVANCED Ø10 L315 WAS NOT PERFORMED AS IT IS NOT APPLICABLE TO THE COMPLAINT CONDITION. THE OBSERVED CONDITION OF THE DEVICE WAS CONSISTENT WITH A RANDOM COMPONENT FAILURE THAT MAY HAVE BEEN CAUSED BY EXPOSURE TO UNINTENDED FORCES. 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 L315 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. G1: MANUFACTURING SITE NAME & ADDRESS CORRECTED H4: DEVICE MANUFACTURE DATE CORRECTED.
DEPUY SYNTHESE IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHESE HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHESE OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHESE, 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. H10 ADDITIONAL NARRATIVE: D2B: ADDITIONAL PRODUCT CODE: HWC D9: COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION BUT HAS YET TO BE RECEIVED. E3: REPORTER IS A J&J EMPLOYEE. H3, H6: 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. H3, H6: THE DEVICE WAS RECEIVED, THE INVESTIGATION IS IN PROGRESS, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THIS 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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THIS MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
DEVICE REPORT FROM SYNTHESE REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT ORIF SURGERY WITH TNA NAILS. THE SURGEON INSERTED THE NAIL AFTER REAMING AS DESCRIBED IN THE PROCEDURE MANUAL. HOWEVER, WHEN HE TRIED TO PULL THE REAMING ROD OUT OF THE NAIL, HE COULD NOT PULL IT OUT. HE MANAGED TO PULL IT OUT, BUT AROUND 70 MM FROM THE PROXIMAL END OF THE NAIL, IT GOT STUCK AGAIN AND COULD NOT BE PULLED OUT. THE SURGEON FOUND IT IMPOSSIBLE TO REMOVE ONLY THE REAMING ROD, AND THE NAIL ITSELF WAS REMOVED ONCE. (THE SURGERY WAS EXTENDED BY ONE HOUR AT THIS POINT.) HE TRIED TO PULL THE REAMING ROD OUT OF THE PULLED NAIL BUT COULD NOT. THEREFORE, HE CHANGED THE LENGTH OF THE NAIL TO 300 MM, USED A NEW REAMING ROD UPSIDE DOWN, AND THE OPERATION WAS COMPLETED. THE NAIL THAT WAS REMOVED FROM THE BODY SHOWED THAT THE DISTAL INLAY WAS NOT VISUALLY VISIBLE, AND THE PROXIMAL INLAY WAS ALSO OUT OF ALIGNMENT. THEREFORE, THE SURGEON THOUGHT THAT THE TIP OF THE REAMING ROD MAY HAVE BEEN RAISED PROXIMALLY WITH THE DISTAL INLAY HOOKED, PUSHING THE PROXIMAL INLAY UP. THE PATIENT HAD A FRACTURE THAT HAD SHORTENED AND CONTRACTED CONSIDERABLY BECAUSE IT HAD BEEN THREE WEEKS SINCE THE FRACTURE AND NO EXTERNAL FIXATION HAD BEEN PERFORMED. THE FRACTURE COULD NOT BE REPOSITIONED BY TRACTION WITH A DISTRACTOR, SO AN OSTEOTOMY WAS PERFORMED WITH A BONE SAW. THE BONE FRAGMENTS WERE SOMEHOW MESHED, BUT THE DISPLACEMENT WAS NOT COMPLETELY UNDONE. AS THE SURGEON HAMMERED AND INSERTED THE NAIL, A BONE FRAGMENT MAY HAVE ENTERED THE NAIL, CAUSING THE REAMING ROD TO BE STUCK IN IT. THE PATIENT ALSO HAD DIFFICULTY WITH EXTERNAL FIXATION OF THE WOUND DUE TO MENTAL ILLNESS. TOTAL OPERATION TIME FROM SKIN INCISION TO END CAP INSERTION WAS 5 HOURS. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH MORE THAN 120 MINUTES DELAY. THE PATIENT OUTCOME/STATUS WAS STABLE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) TIBIAL NAIL ADVANCED Ø10 L315 THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1467863 | TIBIAL NAIL ADVANCED Ø10 L315 | NAIL, FIXATION, BONE | JDS | SYNTHES GMBH | 1919P89 | 07612334171504 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 45 YR | Male | SYNREAM REAMING ROD ø2.5 SHORT L950.| UNK - NAILS.| UNK - REAMING RODS. |