4.9MM TI LOCKING BOLT 44MM
Report
- Report Number
- 8030965-2018-58822
- Event Type
- Injury
- Date Received
- December 7, 2018
- Date of Event
- January 1, 2018
- Report Date
- November 14, 2018
- Manufacturer
- OBERDORF SYNTHES PRODUKTIONS GMBH
- Product Code
- HSB
- UDI-DI
- 07611819043169
- PMA / PMN Number
- K970733
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- 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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. PATIENT HEIGHT 156 CENTIMETERS, PART 459.440, LOT 5917597: MANUFACTURING SITE: BETTLACH. RELEASE TO WAREHOUSE DATE: JUNE 21, 2012. THE DEVICE HISTORY RECORD SHOWS THIS LOT OF DEVICES WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK OR NONCONFORMITIES NOTED. THIS LOT MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURING PROCESS. THE RAW MATERIAL CERTIFICATE WAS REVIEWED AND THE USED MATERIAL WAS ACCORDING TO SPECIFICATIONS FOR IMPLANTS FOR SURGERY. 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. H3, H6: A PRODUCT INVESTIGATION WAS COMPLETED: THE BOLT IN HAS SHOWN THAT A THREADED PITCH IS FLATTENED. FURTHER INVESTIGATION HAS SHOWN THAT ON THE SURFACE ARE A FEW WEAR MARKS VISIBLE. THE RECEIVED CONDITION OF THE BOLT IS NOT CONCORDANT WITH THE COMPLAINT DESCRIPTION AND THE COMPLAINT CONDITION IS UNCONFIRMED. THIS LOT OF DEVICES WAS MANUFACTURED IN JUNE 2012 ACCORDING TO THE SPECIFICATION. THE REVIEW OF THE PRODUCTION HISTORY REVEALED THAT THIS ARTICLE WAS MANUFACTURED ACCORDING TO THE SPECIFICATIONS. THE PARTS CONFORMED TO DIMENSIONAL / VISUALLY SPECIFICATIONS AT THE TIME OF MANUFACTURING AND PASSED INSPECTION REQUIREMENTS. THEREFORE, ONLY A VISUAL INSPECTION ON THIS BOLT WILL BE PERFORMED. THE LOCKING BOLT SHOWS THAT THE ARTICLE IS IN A USED CONDITION WITHOUT HEAVY DAMAGE. THE SURFACE OF THIS IMPLANT HAS WEAR MARKS IT IS NOT POSSIBLE TO DETERMINE WHERE IT IS COMING FROM. IT IS LIKELY, THAT THIS CAN BE TRACED DURING REMOVAL OR A POSSIBLE INSTABILITY OF THE FRACTURE SITUATION. 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.
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. THE DEVICE WAS RECEIVED, THE INVESTIGATION IS IN PROGRESS, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. CODE 3191 USED TO CAPTURE REQUIRED SURGICAL INTERVENTION AND DEVICE REMOVAL. 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.
REPORTEDLY THE PATIENT WAS IMPLANTED WITH A HIP PROSTHESIS (PROXIMAL FEMUR REPLACEMENT). UPDATED CONCOMITANT DEVICE: PFNA BLADE (PART 04.027.038S, LOT L21XXXX, QUANTITY 1).
THERE WERE FRAGMENTS GENERATED FROM THE BROKEN DEVICES. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. PATIENT OUTCOME WAS UNKNOWN. CONCOMITANT DEVICES: PFNA HELICAL BLADE (PART: 04.027.038S, LOT: UNKNOWN, QUANTITY: 1).
DATE OF EVENT REPORTED AS 2018, EXACT DATE IS NOT KNOWN. ADDITIONAL PRODUCT CODES: HTY, JDW, JDS, JDN. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. 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. 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 EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT PATIENT WAS IMPLANTED WITH A PROXIMAL FEMORAL NAIL ANTIROTATION (PFNA) NAIL AND TWO (2) BOLTS ON (B)(6) 2018. ON UNKNOWN DATE IT WAS REVEALED THAT THE NAIL AND TWO (2) BOLTS WERE BROKEN. THIS REPORT IS FOR ONE (1) LOCKING BOLT THIS IS REPORT 2 OF 3 FOR (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 982465 | 4.9MM TI LOCKING BOLT 44MM | ROD, FIXATION, BONE | HSB | OBERDORF SYNTHES PRODUKTIONS GMBH | 5917597 | 07611819043169 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Required Intervention |