PFNA Ø9 130° L240 TAN
Report
- Report Number
- 8030965-2019-62223
- Event Type
- Injury
- Date Received
- March 25, 2019
- Date of Event
- January 1, 2018
- Report Date
- March 6, 2019
- Manufacturer
- OBERDORF SYNTHES PRODUKTIONS GMBH
- Product Code
- HSB
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
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. G5: DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. 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, H4, H6: PART 472.401S, LOT L934900: MANUFACTURING SITE: BETTLACH. RELEASE TO WAREHOUSE DATE: JUNE 25, 2018. EXPIRY DATE: JUNE 01, 2028. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. 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.
THIS REPORT IS FOR ONE (1) PFNA Ø9 130° L240 TAN.
EXACT DATE IS UNKNOWN. THIS REPORT IS FOR ONE (1) UNKNOWN PFNA NAIL. PART#, LOT# AND UDI # IS NOT AVAILABLE. DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. INITIAL REPORTER IS PATIENT. THIS REPORT IS FOR ONE (1) UNKNOWN PFNA NAIL. PMA/510(K) NUMBER IS NOT AVAILABLE. (B)(4). PRODUCT WAS NOT RETURNED. DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED WITHOUT LOT NUMBER. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND 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 GERMANY AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT HAD A FALL IN THE NIGHT OF EITHER (B)(6) 2018 SUSTAINING A FRACTURED BONE AT THE RIGHT SIDE AND WAS IMPLANTED WITH A PFNA NAIL ON (B)(6) 2018. ON (B)(6) 2018, THE PATIENT UNDERWENT A REVISION PROCEDURE WITH THE USE OF A COMPETITOR DEVICE DUE TO THE PFNA NAIL THAT DID NOT HOLD. THE PATIENT WAS STATING THAT SHE SUFFERED PAIN AND SHE WAS HARMED PHYSICALLY AND MENTALLY. PATIENT AND REVISION SURGERY OUTCOME WERE UNKNOWN. THIS REPORT IS FOR ONE (1) UNKNOWN PFNA NAIL. THIS IS REPORT 1 OF 3 FOR (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 241372 | PFNA Ø9 130° L240 TAN | ROD,FIXATION,INTRAMEDULLARY | HSB | OBERDORF SYNTHES PRODUKTIONS GMBH | L934900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 84 YR | Required Intervention |