11MM/130 DEG TI CANN TFNA 380MM/RIGHT - STERILE
Report
- Report Number
- 8030965-2018-56187
- Event Type
- Injury
- Date Received
- September 7, 2018
- Report Date
- August 22, 2018
- Manufacturer
- OBERDORF SYNTHES PRODUKTIONS GMBH
- Product Code
- HSB
- PMA / PMN Number
- K160167
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
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. DEVICE HISTORY LOT MANUFACTURING LOCATION: (B)(4). MANUFACTURING DATE: 13-MAY-2016. EXPIRATION DATE: 31-MAY-2026. PART NUMBER: 04.037.158S, 11MM/130 DEG TI CANN TFNA 380MM/RIGHT- STERILE. LOT NUMBER: H101665 (STERILE). THIS LOT MET ALL DIMENSIONAL, VISUAL, STERILITY AND PACKAGING CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. COMPONENT PARTS REVIEWED: 04.037.942.2, LOCK PRONG, 130 DEGREE TFNA, BP55. LOT NUMBER: 9914036. 04.037.912.4, WAVE SPRING, SHIM ENDED, BP55. LOT NUMBER: 9850960. 04.037.912.3, TFNA LOCK DRIVE, BP58. LOT NUMBER: H041393. 21127, TIMOAGRI16.00, BP80. LOT NUMBER: 9970309. THE COMPLAINT IS CONFIRMED AS THE BROKEN NAIL IS VISIBLE ON THE RECEIVED PICTURE. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. PRODUCT WAS NOT RETURNED, THEREFORE NO FURTHER INVESTIGATION IS POSSIBLE. 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. VISUAL INSPECTION: VISUAL INSPECTION OF THE RETURNED DEVICE PERFORMED AT CUSTOMER QUALITY CONFIRMED THE CONDITION OF POST OPERATIVE NAIL BREAKAGE, WHICH AGREES WITH THE REPORTED COMPLAINT CONDITION. THE TRANSVERSE BREAK OCCURRED AT THE PROXIMAL LOCKING HOLE. BOTH NAIL PORTIONS WERE RETURNED. DOCUMENT/SPECIFICATION REVIEW: NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED DURING THIS INVESTIGATION. CONCLUSION: A DEFINITIVE ROOT CAUSE FOR THE POST OPERATIVE NAIL BREAKAGE COULD NOT BE DETERMINED BASED ON THE PROVIDED INFORMATION. THIS COMPLAINT IS CONFIRMED HOWEVER NO PRODUCT DESIGN ISSUES OR MANUFACTURING DISCREPANCIES THAT WOULD CONTRIBUTE TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED DURING THIS INVESTIGATION AND THE COMPLAINT CONDITION IS ADEQUATELY COVERED BY THE RISK ASSESSMENT. NO NEW, UNIQUE OR DIFFERENT PATIENT HARMS WERE IDENTIFIED AS A RESULT OF THIS EVALUATION. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. 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. ADDITIONAL NARRATIVE: H3, H4, H6: DHR REVIEW WAS COMPLETED. MANUFACTURING LOCATION: MONUMENT . MANUFACTURING DATE: 13-MAY-2016 . EXPIRATION DATE: 31-MAY-2026. PART NUMBER: 04.037.158S, 11MM/130 DEG TI CANN TFNA 380MM/RIGHT- STERILE . LOT NUMBER: H101665 (STERILE). LOT QUANTITY 5 . WORK ORDER TRAVELER MET ALL INSPECTION ACCEPTANCE CRITERIA. ONE PIECE WAS SCRAPPED IN CELL AT OP #160, QA FINAL INSPECT, FOR POOR SURFACE FINISH. INSPECTION SHEET, IN-PROCESS/INSPECT DIMENSIONAL/FINAL MET ALL INSPECTION ACCEPTANCE CRITERIA APART FROM THE ONE SCRAPPED PIECE. INSPECTION SHEET, TFNA ASSEMBLY INSPECTION MET ALL INSPECTION ACCEPTANCE CRITERIA. PACKAGING LABEL LOG LPPF WAS REVIEWED AND DETERMINED TO BE CONFORMING. SCN SUPPLIED BY ETHICON (ABQ) WAS REVIEWED AND DETERMINED TO BE CONFORMING. THIS LOT MET ALL DIMENSIONAL, VISUAL, STERILITY AND PACKAGING CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. COMPONENT PARTS REVIEWED: 04.037.942.2, LOCK PRONG, 130 DEGREE TFNA, BP55. LOT NUMBER: 9914036 . LOT QUANTITY: 96 . WORK ORDER TRAVELER MET ALL INSPECTION ACCEPTANCE CRITERIA. 04.037.912.4, WAVE SPRING, SHIM ENDED, BP55. LOT NUMBER: 9850960. LOT QUANTITY: 994. WORK ORDER TRAVELER MET ALL INSPECTION ACCEPTANCE CRITERIA. INSPECTION SHEET, INCOMING FINAL INSPECTION MET ALL INSPECTION ACCEPTANCE CRITERIA. MATERIAL CERTIFICATE AND CERTIFICATE OF CONFORMANCE AND QUALITY HISTORY CARD RECEIVED FROM SMALLEY DATED (B)(6)2015 WERE REVIEWED AND DETERMINED TO BE CONFORMING. 04.037.912.3, TFNA LOCK DRIVE, BP58 LOT NUMBER: H041393 LOT QUANTITY: 80 WORK ORDER TRAVELER MET ALL INSPECTION ACCEPTANCE CRITERIA. INSPECTION SHEET MET ALL INSPECTION ACCEPTANCE CRITERIA. 21127, TIMOAGRI16.00, BP80 LOT NUMBER: 9970309 LOT QUANTITY: 2,793 LBS. CERTIFICATE OF ANALYSIS RECEIVED FROM METALWERKS PMB DATED 17-NOV-2015 WAS REVIEWED AND DETERMINED TO BE CONFORMING. LOT SUMMARY REPORT DATED (B)(6)2015 MET ALL INSPECTION ACCEPTANCE CRITERIA. RAW MATERIAL RECEIVING / PUTAWAY CHECKLIST MET ALL INSPECTION ACCEPTANCE CRITERIA. H3, H6: CUSTOMER QUALITY CONDUCTED A REVIEW OF THE PROVIDED PHOTOGRAPH. THE COMPLAINT IS CONFIRMED AS THE BROKEN NAIL IS VISIBLE ON THE RECEIVED PICTURE. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. PRODUCT WAS NOT RETURNED, THEREFORE NO FURTHER INVESTIGATION IS POSSIBLE. 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. H11 CORRECTED DATA: D4: EXPIRATION DATE. H4: MANUFACTURE DATE. 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. 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. ADDITIONAL INFORMATION PROVIDED. INITIAL REPORTER OCCUPATION IS A SYNTHES EMPLOYEE. 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.
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE. EIGHT WEEKS AFTER IMPLANTATION, THE PATIENT CAME IN WITH PAIN. AN X-RAY WAS TAKEN AND IT WAS CONFIRMED THAT A TROCHANTERIC FEMORAL NAILING SYSTEM ADVANCED (TFNA) NAIL BROKE AT THE LAG SCREW INTERFACE. ON AUGUST 22, 2018, THE PATIENT WAS REVISED AND THE IMPLANT WAS REPLACED WITH A NON-SYNTHES SCREW. THE PATIENT AND THE SURGICAL OUTCOME IS UNKNOWN. CONCOMITANT DEVICE TFNA HELICAL BLADE (PART# 04.038.390S, LOT# H573468, QUANTITY# 1) . LOCKING SCREW (PART# 04.005.530, LOT# L364591, QUANTITY# 1) . LOCKING SCREW (PART# 04.005.524, LOT# 9958631, QUANTITY# 1).
CONCOMITANT DEVICES: TFNA HELICAL BLADE 90MM (PART: 04.038.390S, LOT: H573468, QUANTITY: 1), SCREW (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY 1). THIS REPORT IS FOR A TITANIUM (TI) CANNULATED 380MM TFNA NAIL.
PATIENT INFORMATION WAS NOT PROVIDED FOR REPORTING. DATE OF EVENT IS UNKNOWN. THIS REPORT IS FOR ONE (1) UNKNOWN NAIL. PART#, LOT# AND UDI # IS NOT AVAILABLE. DEVICE IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION BUT HAS NOT BEEN RECEIVED YET. THIS REPORT IS FOR ONE (1) UNKNOWN NAIL. PMA/510(K) NUMBER IS NOT AVAILABLE. (B)(4). DEVICE EVALUATION/INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN AS PRODUCT WAS NOT RETURNED TO MANUFACTURER. ADDITIONALLY, DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED WITHOUT 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.
DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE PATIENT UNDERWENT IMPLANT SURGERY. ON AN UNKNOWN DATE POST-OPERATIVE, PATIENT CAME IN PRESENTING WITH PAIN. X-RAY CONFIRMED THAT THE NAIL BROKE AT LAG SCREW INTERFACE. ON (B)(6) 2018, PATIENT WAS REVISED, AND THE IMPLANT WAS REPLACED WITH NON-SYNTHES SCREW. PATIENT AND SURGERY OUTCOME WERE NOT PROVIDED. CONCOMITANT DEVICES REPORTED: TFNA LAB SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1); SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) UNKNOWN NAIL. THIS IS REPORT 1 OF 1 FOR (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 698983 | 11MM/130 DEG TI CANN TFNA 380MM/RIGHT - STERILE | ROD,FIXATION,INTRAMEDULLARY | HSB | OBERDORF SYNTHES PRODUKTIONS GMBH | H101665 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | SEE EVENT DESCRIPTION. |