GUIDEWIRE Ø1.25 W/THREAD-TIP W/TROCAR L1
Report
- Report Number
- 2520274-2016-13242
- Event Type
- Injury
- Date Received
- June 21, 2016
- Date of Event
- June 5, 2016
- Report Date
- June 15, 2016
- Manufacturer
- SYNTHES USA
- Product Code
- LRN
- PMA / PMN Number
- PPREADM
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
(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 WAS USED FOR TREATMENT, NOT DIAGNOSIS. (B)(4). NOT IMPLANTED OR EXPLANTED. DEVICE IS EXPECTED TO BE RETURNED TO SYNTHES MANUFACTURER FOR EVALUATION /INVESTIGATION, BUT HAS YET TO BE RECEIVED. (B)(6). DEVICE HISTORY RECORDS WAS CONDUCTED. THE REPORT INDICATES THAT THE: LOT IS EITHER 9733073 OR 9894439. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. LOT 9733073 / UNSTERILE 9682651. MANUFACTURING SITE: (B)(4), SUPPLIER: (B)(4), MANUFACTURING DATE: 19. NOV. 2015, EXPIRY DATE: 01. NOV. 2025. PART WAS FIRST MANUFACTURED UNSTERILE IN BALSTHAL UNDER THE LOT 9682651, AS THE COMPLAINT IS NOT RELATED TO STERILISATION OR PACKAGING ONLY THE DOCUMENTS OF THE UNSTERILE LOT WERE REVIEWED: NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. LOT 9894439 / UNSTERILE 9881137, MANUFACTURING SITE: (B)(4), SUPPLIER: (B)(4), MANUFACTURING DATE: 05. APRIL. 2016, EXPIRY DATE: 01. MAR. 2026. PART WAS FIRST MANUFACTURED UNSTERILE IN BALSTHAL UNDER THE LOT 9881137, AS THE COMPLAINT IS NOT RELATED TO STERILISATION OR PACKAGING ONLY THE DOCUMENTS OF THE UNSTERILE LOT WERE REVIEWED: NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
UPDATED CIA: TWO GUIDE WIRES, 1.25MM, WITH THREADED-TIP WITH TROCAR, LENGTH 150MM (PART NUMBER 292.620, LOT 9894439 & 9733073) WAS REPORTED AS BROKEN, BUT WAS NOT RETURNED FOR FURTHER EVALUATION. WITHOUT PRODUCT AN INVESTIGATION OR A ROOT CAUSE CANNOT BE PERFORMED/DEFINED. THE DHR REVIEW SHOWS THAT THE DEVICES MET THE SPECIFICATIONS AT THE TIME OF MANUFACTURING AND DISTRIBUTING. DEVICE 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.
UPDATE 24 JUNE 2016 - ADDITIONAL INFORMATION RECEIVED 15 JUNE 2016: THREE ARTICLES WERE AFFECTED IN TOTAL 2X GUIDE WIRE AND 1X DRILL BIT. THE BROKEN OFF PIECES WERE LEFT IN THE PATIENT. THIS REPORT IS 1 OF 3 FOR (B)(4).
DEVICE REPORT FROM SYNTHES ON AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A GUIDE WIRE BROKE DURING SURGERY. THE SURGEON WAS PREVIOUSLY UNHAPPY ABOUT THE DRILL BIT AND REPORTED IT AS BLUNT, HE WAS GIVEN ANOTHER DRILL BIT FROM ANOTHER SET, THESE ARE REUSED DRILL BITS. HE LATER REPORTED THAT THE GUIDE WIRE WAS BROKEN INSIDE THE PATIENT AND THIS WAS A DIRECT RESULT OF USING A BLUNT DRILL BIT. THIS COMPLAINT INVOLVES 1 PART. THIS REPORT IS 1 OF 1 FOR (B)(4).
UPDATED 02.AUGUST 2016:
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 393821 | GUIDEWIRE Ø1.25 W/THREAD-TIP W/TROCAR L1 | WIRE,SURGICAL | LRN | SYNTHES USA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |