10.0 MM FLIP CUTTER II
Report
- Report Number
- 1220246-2024-07145
- Event Type
- Malfunction
- Date Received
- August 12, 2024
- Date of Event
- July 26, 2024
- Report Date
- October 2, 2024
- Manufacturer
- ARTHREX, INC.
- Product Code
- HWE
- UDI-DI
- 00888867004115
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PL
- Reporter Occupation
- 501
Narratives
INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.
THE COMPLAINT ALLEGATION IS CONFIRMED. ONE UNPACKAGED AR-1204AF-100 WAS RECEIVED FOR INVESTIGATION. UPON VISUAL INSPECTION, IT WAS NOTED THAT THE TIP CUTTER OF THE DEVICE WAS DAMAGED. FUNCTIONAL TESTING COULD NOT BE PERFORMED DUE TO THE DAMAGE OF THE DEVICE. THE MOST LIKELY CAUSE OF THE REPORTED FAILURE IS MISUSE, WHICH INVOLVES APPLYING PRYING/LEVERAGING FORCES TO THE DEVICE.
ADDITIONAL INFORMATION: B5, G3, H3, H6 INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.
IT WAS REPORTED THAT DURING AN ARTHROSCOPY AND OSTEOTOMY, AFTER INSERTION INTO THE TISSUE, THE DRILLING TIP OF THE RETROGRADE DRILL BROKE OFF. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.
UPDATE DW (B)(6) 2024: FURTHER INFORMATION WAS PROVIDED THAT THE BROKEN PIECES WERE RETRIEVED OUT OF THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2301594 | 10.0 MM FLIP CUTTER II | MANUAL INSTR, GENERAL SURGICAL | HWE | ARTHREX, INC. | 10.0 MM FLIP CUTTER II | 0282106975 | 00888867004115 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |