6MM/9MM CANNULATED STEPPED DRILL BIT
Report
- Report Number
- 8030965-2019-62302
- Event Type
- Malfunction
- Date Received
- March 28, 2019
- Date of Event
- March 4, 2019
- Report Date
- March 4, 2019
- Manufacturer
- OBERDORF SYNTHES PRODUKTIONS GMBH
- Product Code
- HTW
- UDI-DI
- 07611819642485
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- 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. 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.
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. UPON VISUAL INSPECTION OF THE COMPLAINT DEVICE IT CAN BE SEEN THAT THE CONNECTION PART ON THE DISTAL END OF THE INSTRUMENT IS SNAPED OFF, THIS THUS CONFIRMING THE COMPLAINT DESCRIPTION. FURTHERMORE, THE DISTAL END AND THE BROKEN OFF PART ARE SHOWING SOME SIGNS OF HARD USE. IN ADDITION, THE TIP OF THE INSTRUMENT HAS SIGNS FROM USE ON THE CUTTING EDGES (WEAR). OTHERWISE, THE ARTICLE IS IN A GOOD CONDITION. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. DRAWINGS AND REVISIONS ARE IN ACCORDANCE TO DHR OF PRODUCTION LOT. ALL RELEVANT FEATURES ARE DEFINED ON THE USED DRAWING REVISIONS OF DHR OF PRODUCTION LOT. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED FOR THE AFFECTED LOT, 97 PARTS WERE DELIVERED TO THE WAREHOUSE, NO ABNORMALITIES OR DEVIATIONS WERE DETECTED, WHICH COULD LEAD TO THE COMPLAINT FAILURE. THE ARTICLE WAS MANUFACTURED IN JANUARY 2017. BASED ON DHR REVIEW WE ARE ABLE TO CONFIRM THAT THE RIGHT MATERIAL GOT USED AND THAT THE PART HAD THE RIGHT HARDNESS. NO NCRS WERE MARKED IN THE DHR DURING PRODUCTION. THE INVESTIGATION HAS SHOWN THAT THE CAUSE OF COMPLAINED MALFUNCTION IS A POST-MANUFACTURING CAUSED USE RELATED DAMAGE AT THE DEVICE, THEREFORE NO DIMENSIONAL INSPECTION IS NEEDED. FURTHERMORE THE COMPLAINT RELEVANT DIMENSIONS CANNOT BE CHECKED FOR DIMENSIONAL ACCURACY, BECAUSE OF THE DAMAGE. THERE IS NO PARTICULARIZE INFORMATION WHAT'S HAPPENED TO THIS ARTICLE BY CUSTOMER, UNFORTUNATELY WE ARE NOT ABLE TO DETERMINE THE EXACT REASON FOR THIS OCCURRENCE, BUT WE HAVE TO ASSUME THAT DURING THE OPERATION AN APPLICATION ERROR MAY HAVE TAKEN PLACE. TO PREVENT SUCH PROBLEMS, IT IS NECESSARY WORN OR DAMAGED INSTRUMENTS TO REPLACE AND/OR TO OPERATE ACCORDING TO THE TECHNIQUE GUIDE. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED.
WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. 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. (B)(4). 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 ON (B)(6) 2019, DURING AN UNKNOWN PROCEDURE FOR PROPHYLACTIC FEMORAL NAILING, THE CANNULATED STEPPED DRILL BIT WAS INSERTED INTO AN UNKNOWN CHUCK ATTACHMENT. UPON INSERTION INTO FEMORAL HEAD THROUGH THE TROCHANTERIC FEMORAL NAIL ADVANCE (TFNA) NAIL, THE END PORTION OF THE CANNULATED STEPPED DRILL BIT BROKE OFF IN THE CHUCK ATTACHMENT. THERE WAS NO OTHER CHUCK ATTACHMENTS THAT FIT, SO THE SURGEON HAD TO REMOVE IT WITH UNKNOWN VICE GRIP PLIERS. BROKEN FRAGMENTS WERE EASILY REMOVED WITHOUT ADDITIONAL INTERVENTION. THERE WAS A SURGICAL DELAY OF APPROXIMATELY FIFTEEN (15) MINUTES. THE SURGICAL PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME IS UNKNOWN. CONCOMITANT DEVICES REPORTED: UNKNOWN TFNA NAIL (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY OF 1), UNKNOWN CHUCK (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY OF 1). THIS REPORT IS FOR ONE (1) 6MM/9MM CANNULATED STEPPED DRILL BIT. THIS IS REPORT 1 OF 1 FOR (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 255011 | 6MM/9MM CANNULATED STEPPED DRILL BIT | BIT,DRILL | HTW | OBERDORF SYNTHES PRODUKTIONS GMBH | F-21349 | 07611819642485 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 46 YR | UNK - CHUCK DRILL ATTACHMENT| UNK - NAILS: TFNA| UNK ¿ DRILL |