HELICAL BLADE INSERTER
Report
- Report Number
- 8030965-2018-56966
- Event Type
- Malfunction
- Date Received
- October 3, 2018
- Date of Event
- September 11, 2018
- Report Date
- September 11, 2018
- Manufacturer
- OBERDORF SYNTHES PRODUKTIONS GMBH
- Product Code
- HSB
- UDI-DI
- 07611819642508
- PMA / PMN Number
- K131548
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- 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. DHR REVIEW WAS COMPLETED. PART NUMBER: 03.037.024. SYNTHES LOT NUMBER: T130748 . RELEASE TO WAREHOUSE DATE: 17-MAY-2016 . MANUFACTURE SITE: TUTTLINGEN . PART EXPIRATION DATE: N/A . LIST OF NONCONFORMANCE¿S: NR-0040976 AND NR-0041856 . A NON-CONFORMANCE (NC) WAS STARTED BECAUSE A MANUFACTURING INVESTIGATION CONCLUDED THAT THERE WERE ISSUES DURING THE MANUFACTURE OF THE PRODUCT (LOT # T116450). IT WAS FOUND THAT THE OBSTRUCTION WAS CAUSED BY A DRILLING DISC WHICH WAS PUSHED FORWARD FROM THE GUN DRILLING PROCESS AND LODGED IN THE SMALL CANNULATION Ø6.20MM ±0.04 (CTQ FEATURE). THE LOT # 130748 HAS BEEN IDENTIFIED IN THE NC AS A POTENTIALLY AFFECTED LOT AND WAS BACK ORDERED FOR REWORK. APPROPRIATE STEPS WERE TAKEN TO PERFORM THOROUGH INVESTIGATIONS AND ROOT CAUSE ANALYSIS. A FURTHER NC WAS STARTED BECAUSE THE PACKAGING AND THE INSTRUMENTS OF THE RETURN SHIPMENT WAS DAMAGED DUE TO THE BOUNDING FROM SELZACH DESTRIBUTION CENTER. THE AFFECTED DEVICES (49 PARTS) WERE REWORKED AND FOUND TO BE GOOD IN THE FINAL INSPECTION, 7 DEVICES COULD NOT BE REWORKED DUE TO THE DAMAGE DURING RETURN SHIPMENT AND WERE SCRAPPED. FURTHER REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES AT THE TIME OF MANUFACTURING OF THIS DEVICE AND IT'S SUB COMPONENTS THAT WOULD CONTRIBUTE TO THE COMPLAINT CONDITION. 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 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. DATE REPORTED IN INITIAL MEDWATCH WAS 9/10/2018. CORRECT DATE SHOULD HAVE BEEN 9/11/2018 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. 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, DATE UNKNOWN, THE INVESTIGATION IS IN PROGRESS, 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. 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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. UPDATED EVENT DESCRIPTION PROVIDED FOR REPORTING. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS.
UPDATE 11/26/2018: 03.037.024 TFNA HELICAL-BLADE IMPACT - LOT T130748 WAS THE RECEIVED FROM SJOG BUNBURY HOSPITAL. IT WAS ALSO REPORTED THAT THE SECOND ITEM 03.037.026 CONNECSCR F/TFNA HELIC BLADE+SCR IS A CONSUMABLE AND WOULD HAVE BEEN THROWN OUT AFTER THE PROCEDURE.
IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT UNDERWENT A TROCHANTERIC FIXATION NAILING ADVANCED (TFNA) FOR A FRACTURED FEMORAL NECK. DURING THE PROCEDURE, WHILE LOADING THE HELICAL BLADE ONTO THE HELICAL BLADE IMPACTOR, THE CONNECTING SCREW WAS DIFFICULT TO SCREW IN. THE SURGEON USED A HOCKEY STICK TO SCREW IT. THE SURGEON WAS ABLE TO USE THE INSTRUMENTS, HOWEVER, IT WAS DIFFICULT AND THERE WAS A 5-MINUTE DELAY TO THE PROCEDURE. THERE NO ADVERSE EVENT TO THE PATIENT. CONCOMITANT DEVICES REPORTED: UNKNOWN HELICAL BLADE (PART NUMBER: UNKNOWN, LOT NUMBER: UNKNOWN, QUANTITY:1) . THIS REPORT IS FOR ONE (1) HELICAL BLADE INSERTER . THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).
11/27/2018: UPDATED EVENT DESCRIPTION: IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT UNDERWENT A TROCHANTERIC FIXATION NAILING ADVANCED FOR A FRACTURED FEMORAL NECK. DURING THE PROCEDURE, WHILE LOADING THE HELICAL BLADE ONTO THE HELICAL BLADE IMPACTOR, THE CONNECTING SCREW WAS DIFFICULT TO SCREW IN. THE SURGEON USED A HOCKEY STICK TO SCREW IT. THE SURGEON WAS ABLE TO USE THE INSTRUMENTS, HOWEVER, IT WAS DIFFICULT AND THERE WAS A 5-MINUTE DELAY TO THE PROCEDURE. THERE NO ADVERSE EVENT TO THE PATIENT. CONCOMITANT DEVICES REPORTED: UNKNOWN HELICAL BLADE (PART NUMBER: UNKNOWN, LOT NUMBER: UNKNOWN, QUANTITY:1). HELICAL BLADE INSERTER (PART: 03.037.024, LOT: UNKNOWN, QUANTITY 1) . THIS COMPLAINT INVOLVES TWO (2) DEVICES.
COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED AND IS CURRENTLY PENDING COMPLETION. 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) 2018, THE PATIENT UNDERWENT A TROCHANTERIC FIXATION NAILING ADVANCED FOR A FRACTURED FEMORAL NECK. DURING THE PROCEDURE, WHILE LOADING THE HELICAL BLADE ONTO THE HELICAL BLADE IMPACTOR, THE CONNECTING SCREW WAS DIFFICULT TO SCREW IN AND FELT AS THOUGH IT WAS GETTING CAUGHT ON SOMETHING. THE SURGEON USED A HOCKEY STICK TO SCREW IT. THE SURGEON WAS ABLE TO USE THE INSTRUMENTS; HOWEVER, IT WAS DIFFICULT AND THERE WAS A 5-MINUTE DELAY TO THE PROCEDURE. THERE WAS NO ADVERSE EVENT TO THE PATIENT. CONCOMITANT DEVICES: HELICAL BLADE (PART/LOT NUMBER UNKNOWN, QUANTITY:1). THIS REPORT IS FOR ONE (1) HELICAL BLADE INSERTER. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 771943 | HELICAL BLADE INSERTER | ROD, FIXATION, INTRAMEDULLARY | HSB | OBERDORF SYNTHES PRODUKTIONS GMBH | T130748 | 07611819642508 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |