SCRDRIVERSHAFT-CRUCIF 2.4 L100
Report
- Report Number
- 8030965-2013-03686
- Event Type
- Malfunction
- Date Received
- June 20, 2013
- Report Date
- March 8, 2012
- Manufacturer
- SYNTHES GMBH
- Product Code
- HXX
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TC
- Reporter Occupation
- OTHER
Narratives
ADDITIONAL NARRATIVE: SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE PRESENT SCREWDRIVER WAS ANALYZED FOR CONFORMANCE TO PRINT SPECIFICATIONS AS WELL AS THE DEVICE HISTORY RECORD WAS RESEARCHED;NO ABNORMAL FINDINGS WERE IDENTIFIED. MANUFACTURING AND INSPECTION RECORDS INDICATED NO PROBLEMS WITH THE LOT IN QUESTION. THE FRACTURE FACE OF THE BROKEN TIP IS HOMOGENOUS WHICH INDICATES MATERIAL CONFORMITY. BASED ON THESE FINDINGS WE CONCLUDE THAT THE CAUSE OF FAILURE IS NOT DUE TO ANY MANUFACTURING NON-CONFORMANCES AND WE HAVE TO ASSUME THAT EXCEEDING APPLIED MECHANICAL FORCES LED TO THE BREAKAGE. NOTE THAT THIS IS THE FIRST COMPLAINT WITH THIS ITEM.
IT WAS REPORTED THAT DURING THE FIRST SURGERY WHILE REMOVING A SCREW FROM THE DISTAL RADIUS PLATE, THE TIP BROKE OFF THE SCREW DRIVER HEAD. THE BROKEN PART WAS RETRIEVED AND DISPOSED. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 280031 | SCRDRIVERSHAFT-CRUCIF 2.4 L100 | HXX | SYNTHES GMBH | 7721603 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |