PFNA Ø10 130° L240 SST
Report
- Report Number
- 8030965-2019-59825
- Event Type
- Injury
- Date Received
- January 14, 2019
- Report Date
- December 18, 2018
- Manufacturer
- OBERDORF SYNTHES PRODUKTIONS GMBH
- Product Code
- HSB
- UDI-DI
- 07611819178618
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. UPDATED CONCOMITANT DEVICES THE DEVICE WAS RECEIVED, AND THE PRODUCT EVALUATION IS IN PROGRESS. NO CONCLUSION CAN BE DRAWN. ADDITIONALLY, DEVICE HISTORY RECORDS REVIEW HAS BEEN REQUESTED. CORRECTED DATA: LOT NUMBER 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 HISTORY RECORDS REVIEW WAS COMPLETED FOR PART: 272.265S, LOT: L900473. MANUFACTURING LOCATION: BETTLACH, RELEASE TO WAREHOUSE DATE: JUN 13,2018, EXPIRY DATE: JUN 01, 2028. THE DEVICE HISTORY RECORD SHOWS THIS LOT WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK OR NONCONFORMITIES NOTED. THIS LOT MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURING PROCESS. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. PRODUCT INVESTIGATION WAS COMPLETED. DURING THIS INVESTIGATION, THREE FROM FOUR DIMENSIONS OF THE NAIL WHICH ARE RELEVANT FOR THE COMPLAINT CONDITION WERE MEASURED AND HAVE FULFILLED THEIR SPECIFICATIONS ACCORDING TO THE DRAWING. THE POSITION FROM THE OBLONG HOLE 5.1 COULD NOT MEASURE AFTER BENDING. BESIDES, DURING THE MANUFACTURING PROCESS THESE FEATURES WERE INSPECTED THROUGH THE INSPECTION SHEET AND THE WHOLE LOT HAS PASSED ITS SPECIFICATIONS. THEREFORE, THE NAIL WAS MANUFACTURED ACCORDING TO ITS QUALITY STANDARDS AND ANY MANUFACTURING ISSUE CAN BE EXCLUDED. BASED ON THE INVESTIGATION RESULT THIS COMPLAINT IS RATED AS CONFIRMED SINCE THE NAIL IS BROKEN AS CLAIMED BY THE CUSTOMER. HOWEVER, FROM THE MANUFACTURING POINT OF VIEW THE RELEVANT FEATURES WERE MEASURED AND HAVE FULFILLED ITS SPECIFICATION AS WELL AS IN THE MANUFACTURING DOCUMENTATION REVIEWED NO ISSUE WAS IDENTIFIED. DUE TO ANY MANUFACTURING HAS BEEN EXCLUDED; THIS COMPLAINT IS RATED AS NOT VALID, THEREFORE NO ADDITIONAL ACTIONS ARE REQUIRED. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED AS NO PRODUCT RELATED ISSUE COULD BE DETECTED 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.
CONCOMITANT DEVICES: PFNA BLADE (PART # 02.027.037S, LOT # L212727, QUANTITY 1). LOCKING BOLT (PART # 259.400, LOT # L734557, QUANTITY 1).
DEVICE IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS NOT BEEN RECEIVED YET. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. (B)(4). PRODUCT WAS NOT RETURNED. 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 EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2018, PATIENT WAS IMPLANTED WITH PROXIMAL FEMORAL NAIL ANTIROTATION (PFNA) NAIL. ON AN UNKNOWN DATE THE PATIENT EXPERIENCED PAIN SEVERAL MONTHS AFTER IMPLANTATION OF PFNA NAIL. ON (B)(6) 2018, X-RAY CONFIRMED THAT THE PFNA NAIL WAS BROKEN. THE PATIENT UNDERWENT A REVISION SURGERY DUE TO A BROKEN PROXIMAL FEMORAL NAIL ANTIROTATION (PFNA) NAIL AT THE AREA OF THE HOLE FOR BOLT ON (B)(6) 2018. THE PATIENT WAS REVISED TO ANOTHER PFNA NAIL. THERE WAS NO SURGICAL DELAY REPORTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT STATUS WAS UNKNOWN. CONCOMITANT DEVICES: PFNA BLADE (PART UNKNOWN, LOT UNKNOWN, QUANTITY 1). SCREW (PART UNKNOWN, LOT UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) PFNA NAIL. THIS IS REPORT 1 OF 1 FOR (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 35960 | PFNA Ø10 130° L240 SST | ROD,FIXATION,INTRAMEDULLARY | HSB | OBERDORF SYNTHES PRODUKTIONS GMBH | L900473 | 07611819178618 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |