8.0MM DRILL BIT FOR DHS/DCS TRIPLE REAMER
Report
- Report Number
- 8030965-2020-02934
- Event Type
- Malfunction
- Date Received
- April 20, 2020
- Report Date
- March 26, 2020
- Manufacturer
- OBERDORF SYNTHES PRODUKTIONS GMBH
- Product Code
- HTW
- UDI-DI
- 07611819021983
- PMA / PMN Number
- EXEMPT
- 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. INVESTIGATION SITE: CQ ZUCHWIL, SELECTED FLOW: DAMAGE. VISUAL INSPECTION: THE DRILL BIT 8.0MM IS IN WORSE CONDITION. THE VISUAL INSPECTION OF THE DRILL BIT HAS SHOWN THAT THE CUTTING EDGES ARE NICKED, ROUNDED AND QUITE DULL/BLUNT. IN ADDITION, THE TIP BLADES HAD BUILT UP EDGES. THIS EVIDENCE PREVENT A PROPER APPLICATION OF A GUIDE WIRE THROUGH THE CANNULATION OF THE DRILL BIT. DIMENSIONAL INSPECTION: THE RELEVANT FEATURE IS DEFORMED IN A MANNER WHICH PREVENTS ACCURATE MEASUREMENT OF THE FEATURE. A FUNCTIONAL TEST CAN NOT BE PERFORMED OF THE DETECTED DAMAGE. DOCUMENT/SPECIFICATION REVIEW: THE MANUFACTURING REVIEW SHOWS THAT THE PRODUCTION PROCEDURES WERE ACCORDING TO THE SPECIFICATIONS AND THERE WERE NO ISSUES THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE INVESTIGATION HAS SHOWN THAT THE CAUSE OF COMPLAINED MALFUNCTION IS A POST-MANUFACTURING CAUSED USE RELATED DAMAGE AT THE DEVICE. THE REVIEW HAS SHOWN THAT WITH RAW MATERIALS AISI 440A THE CORRECT MATERIAL WAS USED. THE MEASUREMENTS OF THE HARDNESS AFTER THE HARDENING PROCEDURE WERE BETWEEN 53.4 - 54.5 HRC ALSO WITHIN THE SPECIFICATION OF 50.0 - 55.0 HRC. SUMMARY: THE COMPLAINT IS CONFIRMED AS THE THE DRILL BIT IS WORN. THIS PRODUCTION LOT (8043213) WAS MANUFACTURED IN DECEMBER 2012 ACCORDING TO THE SPECIFICATION. THE PARTS CONFORMED TO DIMENSIONAL SPECIFICATIONS AT THE TIME OF MANUFACTURING AND PASSED INSPECTION REQUIREMENTS WITH NO NON-CONFORMITIES REPORTED. THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. BASED ON THESE FINDINGS, THE AGE AND THE VERY USED AND DULL CONDITION OF THE DEVICE A MANUFACTURING RELATED ISSUE CAN BE EXCLUDED. WE HAVE TO ASSUME THAT AN EXCESSIVE METALLIC CONTACT CAUSED THE DAMAGE OF THE DRILL BIT. WEAR AND TEAR MAY ALSO HAVE PLAYED A CERTAIN ROLE. IN THIS RELATION, WE WOULD LIKE TO POINT OUT THAT FURTHER HINTS CONCERNING THE LIMITS OF REPROCESSING (E.G. END OF LIFE OF A DEVICE) CAN BE FOUND IN THE IMPORTANT INFORMATION LEAFLET. 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 HISTORY LOT PART: 338.100, LOT: 8043213, MANUFACTURING SITE: HÄGENDORF, RELEASE TO WAREHOUSE DATE: DEC. 13, 2012. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. 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. H3, H6: PART: 338.100 LOT: 8043213 MANUFACTURING SITE: HÄGENDORF RELEASE TO WAREHOUSE DATE: DECEMBER 13, 2012 A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. VISUAL INSPECTION: THE VISUAL INSPECTION OF THE DRILL BIT HAS SHOWN THAT THE CUTTING EDGES ARE NICKED, ROUNDED AND QUITE DULL/BLUNT. IN ADDITION, THE TIP BLADES HAD BUILT UP EDGES. THIS EVIDENCE PREVENTS A PROPER APPLICATION OF A GUIDE WIRE THROUGH THE CANNULATION OF THE DRILL BIT. DIMENSIONAL INSPECTION: THE RELEVANT FEATURE IS DEFORMED IN A MANNER WHICH PREVENTS ACCURATE MEASUREMENT OF THE FEATURE. A FUNCTIONAL TEST CAN NOT BE PERFORMED OF THE DETECTED DAMAGE. DOCUMENT/SPECIFICATION REVIEW: THE MANUFACTURING REVIEW SHOWS THAT THE PRODUCTION PROCEDURES WERE ACCORDING TO THE SPECIFICATIONS AND THERE WERE NO ISSUES THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE INVESTIGATION HAS SHOWN THAT THE CAUSE OF COMPLAINED MALFUNCTION IS A POST-MANUFACTURING CAUSED USE RELATED DAMAGE AT THE DEVICE. THE REVIEW HAS SHOWN THAT THE CORRECT RAW MATERIAL WAS USED. THE MEASUREMENTS OF THE HARDNESS AFTER THE HARDENING PROCEDURE WERE WITHIN THE SPECIFICATION. SUMMARY: THE COMPLAINT IS CONFIRMED AS THE THE DRILL BIT IS WORN. THIS PRODUCTION LOT (8043213) WAS MANUFACTURED IN DECEMBER 2012 ACCORDING TO THE SPECIFICATION. THE PARTS CONFORMED TO DIMENSIONAL SPECIFICATIONS AT THE TIME OF MANUFACTURING AND PASSED INSPECTION REQUIREMENTS WITH NO NON-CONFORMITIES REPORTED. THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. BASED ON THESE FINDINGS, THE AGE, AND THE VERY USED AND DULL CONDITION OF THE DEVICE, A MANUFACTURING RELATED ISSUE CAN BE EXCLUDED. WE HAVE TO ASSUME THAT AN EXCESSIVE METALLIC CONTACT CAUSED THE DAMAGE OF THE DRILL BIT. WEAR AND TEAR MAY ALSO HAVE PLAYED A CERTAIN ROLE. IN THIS RELATION, WE WOULD LIKE TO POINT OUT THAT FURTHER HINTS CONCERNING THE LIMITS OF REPROCESSING (E.G. END OF LIFE OF A DEVICE) CAN BE FOUND IN THE IMPORTANT INFORMATION LEAFLET. 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.
THIS COMPLAINT INVOLVES THREE (3) DEVICES.
REPORTER IS A SYNTHES EMPLOYEE. THE 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 REPORTS AN EVENT IN THE (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING AN UNKNOWN PROCEDURE, THAT THE STYLET WAS INSERTED IN THROUGH THE CANNULATION TO PUSH A GUIDEWIRE, WHICH WAS STICKING. THE STYLET BECAME STUCK IN THE CANNULATION. THERE WAS A FIVE (5) TO TEN (10) MINUTE SURGICAL DELAY, WHICH WAS DUE TO RETRIEVING ANOTHER TRAY FOR THE PROCEDURE. IT IS UNKNOWN IF THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT WAS NOT IMPACTED. CONCOMITANT DEVICES REPORTED: REAMERS ( PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY 1), GUIDE/COMPRESSION/K-WIRES (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY 1). THIS REPORT INVOLVES ONE (1) 8.0MM DRILL BIT FOR DHS/DCS TRIPLE REAMER. THIS IS REPORT 1 OF 1 FOR (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 442475 | 8.0MM DRILL BIT FOR DHS/DCS TRIPLE REAMER | BIT,DRILL | HTW | OBERDORF SYNTHES PRODUKTIONS GMBH | 8043213 | 07611819021983 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | DHS/DCS-GUIDEWIRE Ø2.5 W/THREAD-TIP W/TR| DRILL BIT Ø8 L245 F/DHS/DCS-SYST| UNK - GUIDE/COMPRESSION/K-WIRES| UNK - REAMERS |