SCREW, FIXATION, BONE
Report
- Report Number
- 8030965-2019-61535
- Event Type
- Malfunction
- Date Received
- February 28, 2019
- Report Date
- February 5, 2019
- Manufacturer
- OBERDORF SYNTHES PRODUKTIONS GMBH
- Product Code
- HWC
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- 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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. CORRECTED DATA: PART OF THE SCREW REMAINED IN THE PATIENT¿S BONE; DEVICE NOT CONSIDERED EXPLANTED. 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. PATIENT ID ALSO REPORTED AS (B)(6). 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.
THE RECEIVED X-RAYS AND PICTURE CONFIRM THE ISSUE AS PER EVENT DESCRIPTION; THE COMPLAINT THEREFORE HAS BEEN DETERMINED TO BE CONFIRMED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND 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. 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.
ALL LOCKING SCREW SHAFTS WERE RETAINED IN THE PATIENT.
IT WAS REPORTED THAT ON (B)(6) 2019, AN IMPLANT REMOVAL WAS PERFORMED ON A PATIENT TREATED FOR LISFRANC LUXATION FRACTURE ON THE FOOT. INITIALLY, AN UNKNOWN SYNTHES FOOT SYSTEM WAS IMPLANTED 11 MONTHS AGO. DURING REMOVAL, THE HEAD OF FIVE (5) UNKNOWN LOCKING SCREWS ON THE TWO (2) VARIABLE ANGLE (VA) LOCKING X-PLATES BROKE OFF AND ONE (1) CORTICAL SCREW WAS FOUND ALREADY BROKEN IN SITU. THE BROKEN CORTICAL SCREW WAS DIFFICULT/UNABLE TO BE REMOVED. SHAFTS OF THE BROKEN LOCKING SCREWS WERE RETAINED IN THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THIRTY (30) MINUTES SURGICAL DELAY. PATIENT OUTCOME WAS FULL RECOVERY. CONCOMITANT DEVICES: VA LOCKING X-PLATES (PART: 04.211.201, LOT: UNKNOWN, QUANTITY: 2), SCREWS (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 4).
IT WAS REPORTED THAT ON (B)(6), 2019, AN IMPLANT REMOVAL WAS PERFORMED WITH PATIENTS CONDITION AFTER LISFRANC LUXATION FRACTURE ON THE FOOT. INITIALLY, AN UNKNOWN SYNTHES FOOT SYSTEM WAS IMPLANTED 11 MONTHS AGO. DURING REMOVAL, THE HEAD OF THE FIVE (5) UNKNOWN LOCKING SCREWS ON THE TWO (2) VARIABLE ANGLE (VA) LOCKING X-PLATES BROKE OFF AND ONE (1) CORTICAL SCREW WAS ALREADY BROKEN IN SITU. THE CORTICAL SCREW WAS NOT STUCK ON THE PLATE BUT WAS DIFFICULT/UNABLE TO BE REMOVED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED 30 MINUTES SURGICAL DELAY. PATIENT HAS FULL RECOVERY. CONCOMITANT MEDICAL PRODUCTS: VA LOCKING X-PLATES (PART #: 04.211.201, LOT #: UNKNOWN, QUANTITY: 2) AND UNKNOWN SCREWS (PART #: UNKNOWN, LOT #: UNKNOWN, QUANTITY: 4).
THIS REPORT IS FOR SEVEN (7) UNKNOWN SCREWS/UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN; UDI NUMBER IS UNKNOWN. EXACT IMPLANT DATE IS UNKNOWN; REPORTED AS 11 MONTHS AGO. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. 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. 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 (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, AN IMPLANT REMOVAL WAS PERFORMED WITH PATIENT¿S CONDITION AFTER LISFRANC LUXATION FRACTURE ON THE FOOT. INITIALLY, AN UNKNOWN SYNTHES FOOT SYSTEM WAS IMPLANTED ELEVEN (11) MONTHS AGO. DURING REMOVAL, THE HEAD OF THE SEVEN (7) UNKNOWN SCREWS ON THE TWO (2) UNKNOWN PLATES BROKE OFF AND ONE (1) CORTICAL SCREW WAS ALREADY BROKEN IN SITU. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PATIENT OUTCOME WAS UNKNOWN. CONCOMITANT DEVICE REPORTED: FOOT PLATE PLATES (PART/LOT UNKNOWN, QUANTITY 2). THIS REPORT IS FOR SEVEN (7) UNKNOWN SCREWS. THIS IS REPORT 1 OF 2 FOR (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 173504 | SCREW, FIXATION, BONE | HWC | OBERDORF SYNTHES PRODUKTIONS GMBH |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |