TI TOMOFIX MEDIAL HIGH TIB PL LT/ANAT/4 HOLES/112MM/STER
Report
- Report Number
- 8030965-2018-57088
- Event Type
- Injury
- Date Received
- October 8, 2018
- Date of Event
- January 1, 2018
- Report Date
- September 18, 2018
- Manufacturer
- OBERDORF : SYNTHES PRODUKTIONS GMBH
- Product Code
- HRS
- UDI-DI
- 07612334080240
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- 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. A PRODUCT INVESTIGATION WAS CONDUCTED. PART UPON RECEPTION: THE PLATE WAS RECEIVED ON NOVEMBER 05, 2018. THE PLATE IS BROKEN INTO TWO PIECES. A FEW SMALL SCRATCHES ARE VISIBLE ON THE TOP SURFACE AND ONE BIGGER, ABOUT 4MM LONG AND 1MM WIDE SCRATCH IS VISIBLE ON THE BOTTOM. THE DECONTAMINATION FORM IS ATTACHED IN PAPER. NO SCREWS HAVE BEEN RETURNED WITH THE PLATE. THE PART IS IDENTIFIED AS: ARTICLE # 440.837S (TOMOFIXTIBPL ANATOM MED PROX LI KO 4LO L) / LOT # L567825. RAW MATERIAL: THE FOLLOWING RAW MATERIAL HAS BEEN USED TO PRODUCE THIS PLATE: TAFEL 4.0 X 400 X 500MM TICP HAS / ARTICLE # 60082115 / LOT # L220287. THIS IS A SEMI-FINISHED RAW MATERIAL, MADE FROM ARTICLE # 60010278 / LOT # 19072 THE RAW-MATERIAL CERTIFICATE IS ATTACHED. IT IS FOUND TO BE IN SPECIFICATION. NO OTHER INVESTIGATION PERFORMED IN RARON SINCE THE RELEASE OF THAT RAW MATERIAL ON SEPTEMBER 25, 2015 CONTAINS THE RAW MATERIAL LOT # 19072. DHR REVIEW: A DHR REVIEW WAS PERFORMED. THE FOLLOWING WORK ORDERS LED TO THE FINISHED PRODUCT: BLANK PRODUCT ARTICLE # 60132794; LOT # L537438: WORK ORDER WAS PRINTED ON AUGUST 09, 2017 AND RELEASED ON AUGUST 09, 2017. NOTHING UNUSUAL IS DOCUMENTED ON THE WORK ORDER. OUT OF THE 120 PARTS, 10 WERE FOUND TO BE OUT OF SPECIFICATION AFTER STEP 0040 ¿FANUC_AM MILLING¿. THE REMAINING 110 BLANKS WERE FURTHER PROCESSED ACCORDING TO THE DHR AND WERE FOUND IN SPECIFICATION. FINISHED PRODUCT ARTICLE # 440.837; LOT # L567825: WORK ORDER WAS PRINTED ON AUGUST 31, 2017 AND RELEASED ON AUGUST 31, 2017. NOTHING UNUSUAL IS DOCUMENTED ON THE WORK ORDER. THE FULL LOT (12 PARTS) WAS PRODUCED AND FOUND TO BE IN SPECIFICATION. PLATE: THE FOLLOWING POINTS ARE HIGHLIGHTED IN RELATION TO THIS PRODUCT INVESTIGATION: THE PLATE IS BROKEN AT HOLE D. INVESTIGATION OF CRITICAL FEATURES ON COMPLAINT PART: THE CRITICAL FEATURES WERE VERIFIED ON THE COMPLAINT PART. ALL MEASUREMENTS TAKEN ALIGN WITH THE RESULTS ON THE TESTS AND MEASUREMENTS PERFORMED DURING PRODUCTION. ALL MEASUREMENTS OF THE MEASURABLE FEATURES OF THE RECEIVED ARTICLE WERE FOUND TO BE IN SPECIFICATION. CONCLUSION: THE PLATE WITH THE ARTICLE # 440.837, LOT # L567825 (TOMOFIXTIBPL ANATOM MED PROX LI KO 4LO L) WAS PRODUCED AS IT INTENDED. NO PROCESS DEVIATIONS WERE DETECTED. THEREFORE, THE COMPLAINT PC-000284499 IS ACKNOWLEDGED BUT NOT VALID FROM THE MANUFACTURING SITE POINT OF VIEW. NO MANUFACTURING RELATED ISSUE WAS IDENTIFIED AND/OR CONFIRMED, THEREFORE A FURTHER REVIEW OF THE SPECIFIC PRM AND PRM LINE IS NOT REQUIRED. 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: DEVICE EVALUATED BY MFR, DEVICE MANUFACTURE DATE, EVALUATION CODES: DEVICE HISTORY RECORD (DHR) REVIEW: PART: 440.837S; LOT: L567825; MANUFACTURING SITE: RARON; SUPPLIER: RELEASE TO WAREHOUSE DATE: 27.SEP.2017; EXPIRY DATE: 01.SEP.2027. THE DEVICE HISTORY RECORD SHOWS THIS LOT OF 17 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. THIS IMPLANT WAS MANUFACTURED FROM FORGING BLANK 60132794 LOT L537438 WHICH WAS MANUFACTURED IN RARON AS WELL. FOR THIS BLANK, THE RAW MATERIAL CERTIFICATE L220287 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 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: THE DEVICE WAS RECEIVED, THE INVESTIGATION IS IN PROGRESS, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING 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.
EVENT OCCURRED ON AN UNKNOWN DATE IN 2018. 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. 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.
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT UNDERWENT OPEN WEDGE HIGH TIBIAL OSTEOTOMY FOR PROXIMAL MEDIAL FRACTURE ON THE LEFT TIBIA WITH TOMOFIX TIBIAL HEAD PLATE ON (B)(6) 2018. ABOUT 4 WEEKS AFTER THE SURGERY, IT WAS FOUND OUT THAT THE PROXIMAL LATERAL BONE ON THE LEFT TIBIA WAS BROKEN. ON (B)(6) 2018, THE SURGERY FOR THE PROXIMAL LATERAL FRACTURE WAS PERFORMED WITH LOCKING COMPRESSION PLATE (LCP) PROXIMAL TIBIAL PLATE. DURING THE SURGERY, THE TOMOFIX PLATE ON THE MEDIAL TIBIA WAS FOUND TO BE BROKEN, SO THE SURGEON DECIDED TO REPLACE THE PLATE WITH A NEW TOMOFIX TIBIAL HEAD PLATE. THE SURGERY WAS EXTENDED BY 90 MINUTES AS THE SURGEONS HAD TO WAIT FOR A NEW PLATE TO ARRIVE. THERE WAS AN EXTRA, 7 CENTIMETER, INCISION TO REPLACE THE DEVICE. THE SURGEON THOUGHT THE BREAKAGE OF THE PLATE OCCURRED BECAUSE OF THE LATERAL HINGE OF THE SECOND FRACTURE, NOT DUE TO THE TOMOFIX PLATE ITSELF. THE HOSPITAL PLANS TO MAKE THE NO-WEIGHT BEARING PERIOD LONGER THAN USUAL. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT OUTCOME IS UNKNOWN. THIS REPORT IS FOR ONE (1) TI TOMOFIX MEDIAL HIGH TIB PL LT/ANAT/4 HOLES/112MM/STER. THIS IS REPORT 1 OF 1 FOR (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 782743 | TI TOMOFIX MEDIAL HIGH TIB PL LT/ANAT/4 HOLES/112MM/STER | PLATE,FIXATION,BONE | HRS | OBERDORF : SYNTHES PRODUKTIONS GMBH | L567825 | 07612334080240 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Required Intervention |