4.9MM TI LOCKING BOLT 42MM
Report
- Report Number
- 8030965-2017-50260
- Event Type
- Injury
- Date Received
- December 4, 2017
- Report Date
- November 6, 2017
- Manufacturer
- OBERDORF SYNTHES PRODUKTIONS GMBH
- Product Code
- HSB
- UDI-DI
- 07611819043152
- PMA / PMN Number
- K970733
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NZ
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
ADDITIONAL NARRATIVE: DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE HISTORY RECORD REVIEW: MANUFACTURING LOCATION: (B)(4). RELEASE TO WAREHOUSE DATE: 26.MAR.2015. NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A PRODUCT DEVELOPMENT INVESTIGATION WAS PERFORMED FOR THE SUBJECT DEVICE (LOCKING BOLT, PART NUMBER 459.420, LOT NUMBER 5933678). THE SUBJECT DEVICE WAS RETURNED WITH THE COMPLAINT CONDITION STATING THE UPON VISUAL INSPECTION THE LOCKING BOLT IS BROKEN IN TWO PARTS. THE TIP WAS NOT PROVIDED FOR INVESTIGATION. THE COMPLAINT IS CONFIRMED DHR REVIEW SHOWED NO ISSUES. A REVIEW OF OUR COMPLAINTS DATA BASE SHOWS, THAT THERE ARE NO OTHER COMPLAINTS FOR THIS ISSUE FROM THIS ARTICLE AND LOT NUMBER. RAW MATERIAL SHOWS CONFORMITY ACCORDING SPECIFICATION. DIAMETER PERTINENT TO COMPLAINT IS ACCORDING SPECIFICATION. NO MANUFACTURING ISSUE IS DETECTED. BASED ON THE INVESTIGATION RESULTS, THIS COMPLAINT IS CONFIRMED SINCE THE NAIL IS BROKEN AS CLAIMED BY THE CUSTOMER. CQ "X-RAY" EVALUATION, WE ARE ABLE TO CONFIRM A BROKEN NAIL AND A BROKEN SCREW ON THE RECEIVED X-RAY. THE ROOT CAUSE FOR THE MALFUNCTION IS UNKNOWN. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
PATIENT¿S IDENTIFIER, DATE OF BIRTH AND WEIGHT ARE NOT AVAILABLE FOR REPORTING. DATE OF POSTOPERATIVE BOLT BREAKAGE IS UNKNOWN. ADDITIONAL DEVICE PRODUCT CODES: HTY, JDW, JDS, JDN. IMPLANTED 18 MONTHS PRIOR TO REVISION SURGERY. DEVICE NOT FULLY EXPLANTED ON (B)(6) 2017, PARTIAL DEVICE REMAINED IN THE PATIENT. THERAPY DATE IS 18 MONTHS PRIOR TO REVISION SURGERY. REPORTER PHONE NUMBER IS UNKNOWN. THE SUBJECT DEVICE HAS BEEN RECEIVED AND THE PRODUCT EVALUATION IS IN PROGRESS. NO CONCLUSION CAN BE DRAWN. 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 A PROXIMAL FEMORAL NAIL ANTIROTATION (PFNA) WAS INSERTED ABOUT 18 MONTHS AGO. POSTOPERATIVE X-RAYS TAKEN ON (B)(6) 2017 REVEALED THAT THE NAIL AND THE DISTAL LOCKING BOLT ARE BROKEN. APPARENTLY, THE LOCKING BOLT HAD BROKEN A FEW MONTHS EARLIER BUT DUE TO NONUNION OF THE FRACTURE THE NAIL THEN FAILED AT THE JUNCTION OF THE BLADE INSERTION HOLE. THE PFNA NAIL WAS REVISED ON (B)(6) 2017 TO A RECON EXPERT LATERAL FEMORAL NAIL (LFN)L, 13MM X 260 AND 2 6.5MM RECON SCREWS AND 2 5.0MM DISTAL LOCKING SCREWS. THERE WAS 180-MINUTE DELAY TO PROCEDURE. TIP OF THE 4.9 MM LOCKING BOLT IS STILL IN PATIENT AND COULD NOT BE RECOVERED. ACTION TAKEN TO MANAGE PROBLEM DURING PROCEDURE. USED EVERY TECHNIQUE AVAILABLE TO TRY AND REMOVE THE DISTAL PART OF THE NAIL, EVENTUALLY THE EASY OUT FROM THE OPERACE SYSTEM WAS SUCCESSFUL. CONCOMITANT DEVICE REPORTED: PFNA BLADE (PART # 04.027.039S, LOT # 9695724, QUANTITY 1). THIS REPORT IS FOR ONE (1) 4.9MM TI LOCKING BOLT 42MM. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 860459 | 4.9MM TI LOCKING BOLT 42MM | ROD,FIXATION,INTRAMEDULLARY | HSB | OBERDORF SYNTHES PRODUKTIONS GMBH | 5933678 | 07611819043152 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |