3.5MM LOCKING SCREW SELF-TAPPING 22MM
Report
- Report Number
- 8030965-2023-14029
- Event Type
- Injury
- Date Received
- November 7, 2023
- Date of Event
- October 6, 2023
- Manufacturer
- SYNTHES GMBH
- Product Code
- KTT
- PMA / PMN Number
- K000684
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- 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. H3, H4, H6 INVESTIGATION SUMMARY 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 LOCKSCR Ø3.5 SELF-TAP L22 SST WAS BROKEN ACROSS THE NECK BETWEEN THE HEAD AND THE SHAFT, ONLY THE HEAD FRAGMENT WAS RETURNED IN THE EVIDENCE PROVIDED. EMBEDDED DEVICE CONDITION CANNOT BE CONFIRMED SINCE PHOTOS OR X-RAY EVIDENCE WERE NOT PROVIDED. A DIMENSIONAL INSPECTION FOR THE LOCKSCR Ø3.5 SELF-TAP L22 SST WAS NOT PERFORMED DUE TO POST MANUFACTURING DAMAGE. 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 LOCKSCR Ø3.5 SELF-TAP L22 SST 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. DRAWING/SPECIFICATIONS REVIEWED? REVIEWED DIMENSIONAL INSPECTION: N/A. DEVICE HISTORY A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE PRODUCT CODE # 213.022, LOT # 2353P93. IT WAS ELECTRONICALLY REVIEWED AND NO NONCONFORMANCES / MANUFACTURING IRREGULARITIES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS. THE PRODUCT WAS RELEASED ON: 14-OCT-2022, MANUFACTURING SITE: JABIL GRENCHEN. 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. D9: COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. D10 THERAPY DATE: (B)(6) 2023. H3, H4, H6: WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. 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.
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN FRANCE AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT WAS TREATED IN THE OPERATING ROOM WITH PERFORMANCE OF THE FOLLOWING: - DEROTATION OSTEOTOMY OF THE LEFT FEMUR BY DIRECT APPROACH. - LENGTHENING OF THE LEFT ACHILLES HEEL BY DIRECT APPROACH. - LEFT TIBIOTALAR TRANSPLANT ARTHRODESIS BY DIRECT APPROACH. - LEFT CALCANEO-CUBOID ARTHRODESIS BY DIRECT APPROACH. - INSTALLATION OF A BOOT FOR 2 MONTHS AT THE LEFT. - INSTALLATION OF LCP PLATE DIAM 3.5MM 6 HOLES + 6 SCREWS. ON OCTOBER 6, 2023, THE PATIENT WOKE WITH THE APPEARANCE OF PAIN IN THE AREA OF THE THIGH AND VERY LARGE EDEMA NEXT TO THE THIGH SCAR. CLEAN, NON-INFLAMMATORY SCAR. PAIN AT THE PALPATION OF THE THIGH ON ITS UPPER PART WITHOUT NOTION OF FALL OR TRAUMA. THE RADIOGRAPHIC ASSESSMENT REVEALS A DISPLACEMENT OF THE MATERIAL OF THE LEFT FEMUR. ON OCTOBER 7, 2023 THE PATIENT RETURNED TO THE OPERATING ROOM WITH REMOVAL OF THE MATERIAL AND INSTALLATION OF A SCREW PLATE. FOUR (4) SCREWS COULD BE REMOVED BUT TWO (2) OTHER BROKEN SCREWS COULD NOT BE REMOVED (SCREW HEAD ONLY). THIS REPORT INVOLVES ONE (1) 3.5MM LOCKING SCREW SELF-TAPPING 22MM. THIS IS REPORT 1 OF 7 FOR (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1334896 | 3.5MM LOCKING SCREW SELF-TAPPING 22MM | APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT | KTT | SYNTHES GMBH | 2353P93 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention | LOCKSCR Ø3.5 SELF-TAP L24 SST| UNK - PLATES: LCP| UNK - SCREWS: TRAUMA| UNK - SCREWS: TRAUMA| UNK - SCREWS: TRAUMA| UNK - SCREWS: TRAUMA |