CERAMO FEHLING PUNCH
Report
- Report Number
- 9615005-2022-80006
- Event Type
- Malfunction
- Date Received
- March 3, 2022
- Date of Event
- January 17, 2022
- Report Date
- March 2, 2022
- Manufacturer
- FEHLING INSTRUMENTS GMBH & CO. KG
- Product Code
- HAE
- UDI-DI
- 04058749063394
- PMA / PMN Number
- K153243
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- 501
Narratives
BASED ON THE LOT NUMBER, WE HAVE CHECKED THE DHR: NO FINDINGS WE WILL EXAMINE THE DEVICE AS SOON AS POSSIBLE.
BASED ON THE LOT NUMBER, WE HAVE CHECKED THE DHR: NO FINDINGS. THE FOOT OF THE PUNCH BROKE OFF, BUT THE BROKEN PIECE WASN'T RETURNED. MICROSCOPE PHOTOS SHOW SERIOUS DEFORMATIONS OF THE CUTTING EDGE OF THE SLIDER. BASED ON THESE FINDINGS, WE ASSUME THAT THE BREAKAGE WAS CAUSED BY OVERLOADING DUE TO CUTTING TOO HARD MATERIAL. (SEE ENCLOSED PICTURES) THE PUNCH IS MADE OF HARDENED STEEL AND IS USED FOR PUNCHING BONE STRUCTURES THINNED OUT BY MILLING. WHEN USED PROPERLY, IT IS NOT POSSIBLE FOR LIPPAGE OF THIS TYPE TO OCCUR ON THE CUTTING EDGE. A MATERIAL OR MANUFACTURING DEFECT CAN BE RULED OUT DUE TO THE HOMOGENEOUS STRUCTURE OF THE FRACTURE SURFACE.
A CERVICAL KERRISION BROKE DURING THE PROCEDURE WHILE IN USE. ALL PIECES WER RETRIEVED BY THE SURGEON.
A CERVICAL KERRISION BROKE DURING THE PROCEDURE WHILE IN USE. ALL PIECES WER RETRIEVED BY THE SURGEON.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 653937 | CERAMO FEHLING PUNCH | EJECTOR PUNCH | HAE | FEHLING INSTRUMENTS GMBH & CO. KG | NNR-0F | X17J543WM | 04058749063394 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention |