| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | OSTYCUT BONE BIOPSY NEEDLE | BONE BIOPSY NEEDLE | ANGIOMED GMBH & CO. MEDIZINTECHNIK KG | DWO | R | N |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2017-05-02 | 0 | 1. S |
Patient 1
THE DEVICE HISTORY RECORDS ARE BEING REVIEWED. THE EVENT IS CURRENTLY UNDER INVESTIGATION. THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT WAS UNABLE TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD.
Patient 1
IT WAS REPORTED THAT THE DISTAL TIP OF THE BONE BIOPSY NEEDLE DETACHED DURING THE BIOPSY PROCEDURE AND WAS LEFT IN THE PATIENT.
Patient 1
AS NO LOT NUMBER WAS PROVIDED, A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. AS PART OF ALL COMPLAINT INVESTIGATIONS, AN ATTEMPT WAS MADE TO EVALUATE THE SUBJECT DEVICE AS WELL AS THE DEVICE USAGE. IN THIS CASE, NO SAMPLE OR IMAGE WAS PROVIDED FOR EVALUATION. THEREFORE, THE REPORTED EVENT COULD NOT BE REPRODUCED. POTENTIAL CONTRIBUTING FACTORS TO THE REPORTED EVENT HAVE BEEN EVALUATED. PREVIOUS INVESTIGATIONS OF SIMILAR COMPLAINTS HAVE BEEN REVIEWED. THIS KIND OF EVENT MAY BE ASSOCIATED WITH IMPROPER HANDLING OF THE NEEDLE DURING INSERTION INTO THE BONE AND/OR REMOVAL FROM THE BONE. ON THE BASIS OF THE LIMITED INFORMATION AVAILABLE AND AS NO SAMPLE WAS RETURNED, A DEFINITE ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE DETERMINED. THE IFU SUPPLIED WITH THIS PRODUCT SUFFICIENTLY DESCRIBES THE CORRECT APPLICATION OF THE DEVICE. THE IFU STATES: "IN CASE THE OSTYCUT DISPOSABLE BONE BIOPSY NEEDLE CANNULA CANNOT BE REMOVED SMOOTHLY FROM THE PUNCTURED BONE AREA, DO NOT ATTEMPT TO LOOSEN THE OSTYCUT DISPOSABLE BONE BIOPSY NEEDLE CANNULA BY OSCILLATING MOVEMENT OF THE CANNULA. INSTEAD, IT IS ADVISED TO LOOSEN AND REMOVE THE OSTYCUT DISPOSABLE BONE BIOPSY NEEDLE CANNULA FROM THE PUNCTURED BONE AREA BY SIMULTANEOUSLY APPLYING COUNTER-CLOCKWISE ROTATION AND TRACTION." AND "LEAVE THE THIN ANESTHESIA NEEDLE IN POSITION AS A GUIDE FOR THE PARALLEL PUNCTURE WITH THE TROCAR POINT OSTYCUT DISPOSABLE BONE BIOPSY NEEDLE. INTRODUCE THE OSTYCUT DISPOSABLE BONE BIOPSY NEEDLE (CANNULA AND STYLET) THROUGH THE INCISION UNTIL CONTACT IS MADE WITH THE AREA TO BE BIOPSIED. WITH THE OSTYCUT DISPOSABLE BONE BIOPSY NEEDLE TIP AT THE BONE SURFACE, ADVANCE THE CANNULA INTO THE BONE UNDER FIRM PRESSURE WHILE ROTATING IT CLOCKWISE. (...) LEAVE THE TROCAR STYLET IN PLACE TO PREVENT THE CANNULA FROM DRIFTING OUT OF THE BIOPSY AREA. AS SOON AS THE THREADED PART OF THE CANNULA OBTAINS A GRIP IN THE BONE, HOLD THE NEEDLE HUB IN PLACE AND WITHDRAW THE STYLET."
Patient 1
IT WAS REPORTED THAT THE DISTAL TIP OF THE BONE BIOPSY NEEDLE DETACHED DURING THE BIOPSY PROCEDURE AND WAS LEFT IN THE PATIENT.