PFNA Ø10 LONG LE 130° L340 TAN
Report
- Report Number
- 8030965-2018-56921
- Event Type
- Injury
- Date Received
- October 2, 2018
- Report Date
- September 10, 2018
- Manufacturer
- OBERDORF SYNTHES PRODUKTIONS GMBH
- Product Code
- HSB
- UDI-DI
- 07611819293168
- 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. THE DEVICE WAS RECEIVED, THE INVESTIGATION IS IN PROGESS, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. CORRECTED DATA: CONCOMITANT DEVICES 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. CONCOMITANT DEVICES UPDATED. ADDITIONAL INFORMATION PROVIDED. CODE 3191 USED TO CAPTURE REQUIRED SURGICAL INTERVENTION AND DEVICE REMOVAL. 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.
ADDITIONAL NARRATIVE: ADDITIONAL INFORMATION. UPDATED REPORTER'S NAME. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED FOR PART: 472.325S, LOT: 9817592: MANUFACTURING SITE: BETTLACH, RELEASE TO WAREHOUSE DATE: 16. FEB. 2016, EXPIRY DATE: 01. FEB. 2026: THE DEVICE HISTORY RECORD SHOWS THIS LOT OF 12 PIECES 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. THE RAW MATERIAL CERTIFICATE 18895 WAS REVIEWED AND THE USED MATERIAL WAS ACCORDING TO ISO-5832-2 SPECIFICATION FOR IMPLANTS FOR SURGERY. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A PRODUCT INVESTIGATION WAS CONDUCTED FOR PART: 472.325S, LOT: 9817592: THE RETURNED BROKEN PFNA NAIL WAS FORWARDED TO THE MANUFACTURING SIDE FOR EVALUATION. THE STATEMENT BELOW IS A SUMMARY OF THEIR INVESTIGATION. AS RELEVANT FOR THE COMPLAINT CONDITION ¿POST-OPERATIVELY A PROXIMAL FEMORAL NAIL ANTIROTAION (PFNA) BROKE¿, THE RELEVANT FEATURES HAVE BEEN IDENTIFIED AND MEASURED. THE OUTER (10 MM) AND INNER DIAMETER (4.4 MM) WERE MEASURED AND HAVE FULFILLED THE SPECIFICATIONS. IN ADDITION, THE ¿RUN-OUT 1MM TO A¿ (ALSO CLASSIFIED AS CTQ -CRITICAL TO QUALITY- ACCORDING TO THE PQP) HAS BEEN IDENTIFIED AS RELEVANT FEATURE DUE TO HAS AN INFLUENCE IN THE THICKNESS. THUS, IF THE NAIL WAS NOT WELL ROUNDED-OUT IT CAN HAVE A NEGATIVE INFLUENCE IN THE BREAKAGE. THEREFORE, HAVING THE INNER DIAMETER AND RUN-OUT WITHIN TOLERANCE; THUS, WE CAN CONCLUDE THAT THE WALL THICKNESS IS ACCORDING ITS TOLERANCE. BESIDES, DURING THE MANUFACTURING PROCESS THESE FEATURES WERE INSPECTED THROUGH THE INSPECTION SHEET AND THE WHOLE LOT HAS PASSED ITS SPECIFICATIONS. THEREFORE, ANY MANUFACTURING ISSUE HAS BEEN 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 SPECIFICATIONS AS WELL AS IN THE MANUFACTURING DOCUMENTATION NO ISSUE WAS IDENTIFIED. DUE TO NO MANUFACTURING ISSUE WAS FOUND AND THIS COMPLAINT IS 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: 04.027.036S, LOT: L790597, QUANTITY: 1), PFNA END CAP (PART: 473.155, LOT: L791324, QUANTITY: 1), 5.0MM TITANIUM LOCKING SCREW 34MM (PART: 04.005.524, LOT: L848518, QUANTITY: 1), 5.0MM TITANIUM LOCKING SCREW 36MM (PART: 04.005.526, LOT: L808559, QUANTITY: 1).
CONCOMITANT DEVICES: PFNA BLADE (PART: 04.027.036S, LOT: L790597, QUANTITY: 1). PFNA END CAP (PART: 473.155, LOT: L791324, QUANTITY: 1). 5.0MM TITANIUM (TI) LOCKING SCREW 34MM (PART: 04.005.524, LOT: L948518, QUANTITY: 1). 5.0MM TITANIUM (TI) LOCKING SCREW 36MM (PART: 04.005.526, LOT: L808559, QUANTITY: 1).
FURTHER IT WAS REPORTED THAT PATIENT WAS INITIALLY IMPLANTED WITH A PROXIMAL FEMORAL NAIL ANTIROTATION (PFNA) SYSTEM ON (B)(6) 2018 TO TREAT THE PERTROCHANTERIC, PROXIMAL FEMORAL FRACTURE ON THE LEFT.
YEAR OF POSTOPERATIVE NAIL BREAKAGE IS REPORTED AS 2018; EXACT DATE IS NOT KNOWN. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. THE (510K): DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED AND IS CURRENTLY PENDING COMPLETION. 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 (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A PATIENT WAS IMPLANTED WITH A PROXIMAL FEMORAL NAIL ANTIROTAION (PFNA) SYSTEM ON (B)(6) 2018. POST-OPERATIVELY, THE PFNA NAIL BROKE ON AN UNKNOWN DATE. HARDWARE WAS EXPLANTED ON (B)(6) 2018. CONCOMITANT DEVICE: PFNA BLADE (PART # 04.027.036S, LOT # L790597, QUANTITY 1). THIS REPORT IS FOR ONE (1) PFNA NAIL. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 769619 | PFNA Ø10 LONG LE 130° L340 TAN | ROD, FIXATION, INTRAMEDULLARY | HSB | OBERDORF SYNTHES PRODUKTIONS GMBH | 9817592 | 07611819293168 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | Required Intervention |