2.7MM VA LCK SCREW SLF-TAP
Report
- Report Number
- 8030965-2018-57744
- Event Type
- Injury
- Date Received
- October 29, 2018
- Report Date
- October 9, 2018
- Manufacturer
- OBERDORF SYNTHES PRODUKTIONS GMBH
- Product Code
- HWC
- UDI-DI
- 07611819435438
- PMA / PMN Number
- K100776
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SN
- Reporter Occupation
- OTHER
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. ADDITIONAL INFORMATION PROVIDED. 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 INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. THE DEVICE WAS RECEIVED, THE INVESTIGATION IS IN PROGESS, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS.
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 COMPLETED: THE 2.7MM VA LOCKING SCREW SELF-TAPPING LENGTH 26 MM IS INTACT, NOTHING IS BROKEN OFF OR BENT. THE LOCKING THREAD ON THE SCREW HEAD IS WORN. A FUNCTIONAL TEST CANNOT BE CONDUCTED AS THE LOCKING THREAD ON THE SCREW HEAD IS WORN. BECAUSE OF THE EXISTING USE RELATED WEAR/DAMAGE ON THE THREADS A DIMENSIONAL INSPECTION CANNOT BE CONDUCTED. THE CAUSE OF THE COMPLAINED MALFUNCTION IS A POST-MANUFACTURING USE RELATED CAUSE AT THE DEVICE. BESIDE THE USE RELATED WEAR ON THE LOCKING HEAD THREAD THE SCREW IS INTACT. WE ARE NOT ABLE TO DETERMINE AN EXACTLY REASON FOR THE SCREW MIGRATION FROM THE VA-LCP DHP 2.7/3.5 PLATE. REFERRING TO THE X-RAY PICTURES AVAILABLE, THREE LOCKING SCREWS WERE NOT SAFELY LOCKED IN THE PLATE AND MIGRATED POST-OPERATIVELY FROM THE THREADED LOCKING BORES OF THE DISTAL HEAD PART OF THE VA-LCP DHP 2.7/3.5 PLATE. THE COMPLAINT THEREFORE IS CONFIRMED. BECAUSE OF THE BREAKAGE OF ONE OF TWO USED VA-LCP DHP 2.7/3.5 PLATE THE WHOLE CONSTRUCT BECAME OVERLOADED AND INSTABLE, WHAT MIGHT PLAYED A CERTAIN ROLE TOO. NO MANUFACTURING RELATED ISSUE WAS IDENTIFIED AND/OR CONFIRMED. 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.
CONCOMITANT DEVICES: WASHER (PART: 219.980, LOT: UNKNOWN, QUANTITY: 1).
ADDITIONAL PRODUCT CODE: HRS. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS.
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2018, PATIENT UNDERWENT AN ELBOW SURGERY IMPLANTATION OF A 2.7MM/3.5MM VARIABLE ANGLE (VA) LOCKING COMPRESSION PLATE (LCP) DISTAL HUMERUS DORSOLATERAL PLATE (4 HOLES, RIGHT SIDE),A 2.7MM/3.5MM VA-LCP DISTAL HUMERUS MEDIAL PLATE (4 HOLES, RIGHT SIDE), SEVEN (7) 2.7MM VA LOCKING SCREWS, A 3.5MM CORTICAL SCREW, A 3.5MM LOCKING SCREWS AND A 4.0MM CANCELLOUS SCREWS WITH WASHER. SEVEN DAYS AFTER THE OPERATION,THE DISTAL VA LOCKING SCREWS BACKED OUT ON THE VA LCP DISTAL HUMERUS DORSOLATERAL PLATE ON UNKNOWN DATE. THE X-RAY WAS REVIEWED AND IDENTIFIED THE FOLLOWING MALFUNCTIONS: ONE (1) BROKEN 4.0MM CANCELLOUS BONE SCREW PARTIALLY THREADED, FOUR (4) 2.7MM VARIABLE ANGLE LOCKING SCREWS SELF-TAPING, TWO (2) MIGRATION OF PLATES THE 2.7MM/3.5MM VARIABLE ANGLE LOCKING COMPRESSION PLATE (LCP) POSTEROLATERAL DISTAL HUMERUS PLATE AND THE 2.7MM/3.5MM VARIABLE ANGLE LOCKING COMPRESSION PLATE (LCP) MEDIAL DISTAL HUMERUS PLATE, AND THE DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2018, PATIENT UNDERWENT AN ELBOW SURGERY IMPLANTATION OF A 2.7MM/3.5MM VARIABLE ANGLE (VA) LOCKING COMPRESSION PLATE (LCP) DISTAL HUMERUS DORSOLATERAL PLATE (4 HOLES, RIGHT SIDE),A 2.7MM/3.5MM VA-LCP DISTAL HUMERUS MEDIAL PLATE (4 HOLES, RIGHT SIDE), SEVEN (7) 2.7MM VA LOCKING SCREWS, A 3.5MM CORTICAL SCREW, A 3.5MM LOCKING SCREWS AND A 4.0MM CANCELLOUS SCREWS WITH WASHER. SEVEN DAYS AFTER THE OPERATION,THE DISTAL VA LOCKING SCREWS BACKED OUT ON THE VA LCP DISTAL HUMERUS DORSOLATERAL PLATE ON UNKNOWN DATE. THE X-RAY WAS REVIEWED AND IDENTIFIED THE FOLLOWING MALFUNCTIONS: ONE (1) BROKEN 4.0MM CANCELLOUS BONE SCREW PARTIALLY THREADED, FOUR (4) 2.7MM VARIABLE ANGLE LOCKING SCREWS SELF-TAPING, TWO (2) MIGRATION OF PLATES THE 2.7MM/3.5MM VARIABLE ANGLE LOCKING COMPRESSION PLATE (LCP) POSTEROLATERAL DISTAL HUMERUS PLATE AND THE 2.7MM/3.5MM VARIABLE ANGLE LOCKING COMPRESSION PLATE (LCP) MEDIAL DISTAL HUMERUS PLATE, AND THERE WERE TWO (2) SCREWS CUTOUT FROM THE MEDIAL PLATE THE 3.5MM/26MM LOCKING SCREW SELF-TAPPING AND 3.5MM/24MM CORTEX SCREW SELF -TAPPING. THE VARIABLE ANGLE ELBOW PLATES WERE NOT BENT BEFORE THE APPLICATION OF THE PLATES AND THE SCREWS WERE SECURELY LOCKED WITH TORQUE LIMITER. IT WAS UNKNOWN IF THERE WERE SURGICAL DELAY AND ADVERSE EVENT TO THE PATIENT REPORTED. A REVISION WAS PERFORMED ON AN UNKNOWN DATE DUE TO BACKED OUT SCREWS. THIS COMPLAINT WILL BE CAPTURED UNDER TWO (2) SEPARATE COMPLAINTS AS (B)(4). WILL CAPTURE THE POST-OP EVENTS, WHERE AN IMPLANTED SEVEN (7) 2.7MM VA LOCKING SCREWS BACKED OUT THAT REQUIRED A REVISION THIS REPORT IS FOR (1) 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 26MM. THIS COMPLAINT INVOLVES FOUR (4) DEVICES. THIS REPORT IS 3 OF 4 FOR (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 857352 | 2.7MM VA LCK SCREW SLF-TAP | SCREW, FIXATION, BONE | HWC | OBERDORF SYNTHES PRODUKTIONS GMBH | 07611819435438 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Required Intervention |