3.5MM TI LOCKING SCR SLF-TPNG W/STARDRIVE RECESS/28MM-STER
Report
- Report Number
- 8030965-2018-57008
- Event Type
- Injury
- Date Received
- October 4, 2018
- Report Date
- May 25, 2018
- Manufacturer
- OBERDORF SYNTHES PRODUKTIONS GMBH
- Product Code
- HSB
- UDI-DI
- 07611819152076
- PMA / PMN Number
- K103002
- 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. H3, H4, H6: DEVICE HISTORY RECORDS REVIEW WAS COMPLETED FOR PART: 412.110S, LOT: 8367723. MANUFACTURING LOCATION: BETTLACH, RELEASE TO WAREHOUSE DATE: MAY 13, 2013, EXPIRY DATE: MAY 01, 2023. 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. THIS IMPLANT WAS MANUFACTURED FROM FORGING BLANK 412.110.999 LOT 1039029 FROM SUPPLIER SFS INTEC AG. 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. H3, H6: PRODUCT INVESTIGATION WAS COMPLETED. ALL DIMENSIONS OF THE BROKEN SCREW RELATED TO THE RETURNED DEVICE, WHICH ARE RELEVANT FOR THE COMPLAINT CONDITION WERE MEASURED AND HAVE FULFILLED THEIR SPECIFICATIONS ACCORDING TO THE DRAWING. BESIDES, DURING THE MANUFACTURING PROCESS THE RELEVANT FEATURES WERE INSPECTED AND DOCUMENTED ACCORDING TO THE INSPECTION SHEET. THEREFORE, THIS SCREW WAS MANUFACTURED ACCORDING TO ITS QUALITY STANDARDS AND A MANUFACTURING ISSUE CAN BE EXCLUDED. THE MATERIAL CERTIFICATE REGARDING TO THE LOT 8367723 (COMP: 412.110.999 / CHARGE NUMBER 01039029) WAS REQUESTED TO SFS SINCE THE BLANKS ARE RECEIVED FROM THAT COMPANY. THE MATERIAL CERTIFICATE WAS REVIEWED, AND IT FULFILLS ITS SPECIFICATIONS. THE RECEIVED CONDITION OF THE ARTICLE AGREES WITH THE COMPLAINT DESCRIPTION SINCE THE SCREW IS BROKEN AS CLAIMED BY THE CUSTOMER. BESIDES, THE COMPLAINT IS CONFIRMED, SINCE THE AVAILABLE DATA SUPPORTS THE COMPLAINANT¿S DESCRIPTION OF THE COMPLAINT CONDITION. HOWEVER, FROM THE MANUFACTURING POINT OF VIEW, NEITHER A DEFECT NOR A DEFICIENCY HAS BEEN IDENTIFIED SINCE NO DEVIATIONS WERE FOUND IN THE DOCUMENTATION AS WELL AS DURING THIS INVESTIGATION ALL RELEVANT MEASUREMENTS PERFORMED ARE ACCORDING TO ITS SPECIFICATIONS. SINCE NO MANUFACTURING ISSUE WAS DETECTED, NO FURTHER ACTIONS HAVE BEEN TAKEN. 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. EVENT: CORRECTED A STATEMENT IN THE DESCRIPTION. 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 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.
PSEUDARTHROSIS OCCURRED AT THE AFFECTED SITE AND THE SCREWS WERE BROKEN DUE TO PRESSURE WHICH WAS APPLIED TO THE AFFECTED SITE IN THE DAILY LIVING ACTIVITY OF THE PATIENT.
CONCOMITANT DEVICE REPORTED: PHILOS 3.5 5HO TI (PART# 441.903S, LOT# 9700390, QUANTITY 1).
DATE OF EVENT: DATE OF POSTOPERATIVE SCREW BREAKAGE IS UNKNOWN. ADDITIONAL DEVICE PRODUCT CODE: KTT. IMPLANTED DATE: UNKNOWN DATE IN (B)(4) 2016. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. THE SUBJECT DEVICE HAS BEEN 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.
DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE IN (B)(6) 2016, PATIENT UNDERWENT REOPERATION USING THE PHILOS - PROXIMAL HUMERAL PLATE 3.5, 5 HOLES, BECAUSE A DISTALLY IMPLANTED SCREW HAD BEEN BROKEN AT THE ROOT OF THE HEAD. AFTER THE REOPERATION, PATIENT VISITED HOSPITAL DUE TO PAIN. ON (B)(6) 2018, IT WAS FOUND THAT THE DISTALLY IMPLANTED FOUR (4) SCREWS HAD BEEN BROKEN AT THE ROOT OF THE HEAD. REPORTEDLY, THE FRACTURED AREA HAS BECOME PSEUD ARTHROSIS. THE PATIENT FEELS A LITTLE PAIN BUT CAN RAISE HIS INJURED ARM AND ALMOST TOUCH HIS HEAD. THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2018. THE PLATE (PHILOS WITH 5 HOLE) AND BROKEN SCREWS WERE REMOVED. ONE BROKEN PIECE OF THE LHS SCREW HEAD REMAINED IN THE PATIENT. PATIENT WAS REVISED TO MULTILOC HUMERAL NAIL (8.0 DIA., 180MM). IT WAS FIXED USING 4 MULTIOCK SCREWS AT THE PROXIMAL AREA OF THE NAIL, AND 2 LOCKING SCREWS AT THE DISTAL AREA OF THE NAIL. THE AFFECTED SITE WAS FILLED WITH THE PIECE OF THE ILIAC BONE. AFTER THE THIRD SURGERY, THE AFFECTED SITE WAS FIXED WITH A TRIANGULAR BANDAGE. PER SURGEON THE SHARP PAIN WAS CAUSED BY THE BROKEN SCREWS. THE PLATE WAS BACKED OUT AND SHIFTED, CAUSING INTERNAL BLEEDING AROUND THE SHAFT OF THE PLATE. PSEUDARTHROSIS OCCURRED AT THE AFFECTED SITE AND THE PLATES WERE BROKEN DUE TO PRESSURE WHICH WAS APPLIED TO THE AFFECTED SITE IN THE DAILY LIVING ACTIVITY OF THE PATIENT. BECAUSE OF PSEUDARTHROSIS WAS THOUGHT TO BE OVEREXPOSURE OF THE PERIOSTEUM, CONSTITUTION, ABSENCE OF INNER BONY SUPPORT. THE PATIENT PUT HER ELBOW ON THE GROUND WHEN SHE STOOD UP. THIS CAUSED EXCESSIVE LOAD APPLIED TO THE AFFECTED SITE AND BROKEN. PATIENT IS IN THE HOSPITAL AND WILL BE DISCHARGED FROM THE HOSPITAL ABOUT A MONTH LATER. THIS (B)(4) CAPTURES THE POST-OPERATIVE PAIN AND THE BREAKAGE OF FOUR (4) SCREWS. THE REOPERATION ON (B)(6) 2016 DUE TO BROKEN SCREW IS CAPTURED UNDER (B)(6). CONCOMITANT MEDICAL PRODUCTS: PHILOS 3.5 5HO TI (PART# 441.903S, LOT# UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) 3.5MM TI LOCKING SCREW 28MM. THIS IS REPORT 2 OF 4 FOR (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 774873 | 3.5MM TI LOCKING SCR SLF-TPNG W/STARDRIVE RECESS/28MM-STER | ROD, FIXATION, INTRAMEDULLARY | HSB | OBERDORF SYNTHES PRODUKTIONS GMBH | 8367723 | 07611819152076 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 80 YR | Required Intervention |