5.0MM TI ANGULAR STABLE LCKNG SCR T25 46MM F/IM NAILS-STER
Report
- Report Number
- 8030965-2023-15973
- Event Type
- Injury
- Date Received
- December 20, 2023
- Date of Event
- September 23, 2023
- Manufacturer
- SYNTHES GMBH
- Product Code
- HSB
- PMA / PMN Number
- K172157
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- 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. 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.
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. H10 ADDITIONAL NARRATIVE: D1, D2, D3, D4, G4-510K: THIS REPORT IS FOR AN UNKNOWN DISTAL LOCKING SCREW/UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN. WITHOUT THE SPECIFIC PART NUMBER; THE UDI NUMBER AND 510-K NUMBER IS UNKNOWN. D9: COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. H3, H4, H6: WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. 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.
PATIENT STATUS/ OUTCOME: PATIENT RECOVERED WITHOUT PERSISTENT DAMAGE.
THE SITE MUE (MÜNSTER, GERMANY) REPORTED AN ADVERSE EVENT IN OUR DATABASE WHICH IS CONSIDERED (POSSIBLY) RELATED TO THE DEVICE. SUBJECT MUE-030. IT WAS REPORTED A HIGH ENERGY TRAUMA ACCIDENT OCCURRED ON (B)(6) 2023 RESULTING IN AN OPEN RIGHT TIBIAL FRACTURE. IT WAS LISTED AS A TYPE IIIC: OPEN FRACTURE ASSOCIATED WITH ARTERIAL INJURY REQUIRING REPAIR. A RIGHT FIBULA WAS ALSO SUSTAINED. SURGERY INCLUDING ARTERY REPAIR WITH DEBRIDEMENT AND EXTERNAL FIXATION OCCURRED ON (B)(6) 2023. WOUND REVISION ONLY OCCURRED ON (B)(6) 2023; DEBRIDEMENT AND ANTIBIOTICS ADMINISTERED. ON (B)(6) 2023, A TIBIAL NAIL AND (B)(4) PROXIMAL SCREW AND (B)(4) DISTAL SCREWS WERE IMPLANTED. ON (B)(6) 2023 INFECTION AND NECROSIS WITH ABSCESS LOWER LEG LAT. RIGHT WAS NOTED. ON (B)(6) 2023, EXTENSIVE DEBRIDEMENT AND NECROSECTOMY WITH A PARTIAL RESECTION OF FIBULA OCCURRED. ON (B)(6) 2023, IMPLANTS WERE REMOVED AND RIGHT LOWER LEG AMPUTATION OCCURRED. PATIENT RECOVERED WITH PERSISTENT DAMAGE. THIS REPORT IS FOR ONE (B)(4) DISTAL LOCKING SCREW. THIS IS REPORT 4 OF 6 FOR COMPLAINT (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2051758 | 5.0MM TI ANGULAR STABLE LCKNG SCR T25 46MM F/IM NAILS-STER | ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES | HSB | SYNTHES GMBH | UDI 07611819302952 (GTIN) | ||
| 289564 | 5.0MM TI ANGULAR STABLE LCKNG SCR T25 46MM F/IM NAILS-STER | ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES | HSB | SYNTHES GMBH | UDI 07611819302952 (GTIN) |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male | Required Intervention | EXPERT TIBIAL NAIL PROTECT Ø10 CANN L300| UNK - SCREWS: NAIL DISTAL LOCKING| UNK - SCREWS: NAIL DISTAL LOCKING| UNK - SCREWS: NAIL DISTAL LOCKING| UNK - SCREWS: NAIL PROXIMAL LOCKING |