FDA Adverse Event
Malfunction
Summary report: N
OSTYCUT DISPOSABLE BONE BIOPSY NEEDLE
MDR report key: 3231790
·
Received July 15, 2013
Report
- Report Number
- 9681442-2013-00076
- Event Type
- Malfunction
- Date Received
- July 15, 2013
- Report Date
- June 19, 2013
- Manufacturer
- ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
- Product Code
- DWO
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE INVESTIGATION IS CURRENTLY UNDERWAY.
Description of Event or Problem · 1
IT WAS REPORTED THAT UPON INSERTION OF THE BIOPSY NEEDLE DURING THE THIRD BIOPSY PASS OF A CLAVICLE BONE BIOPSY PROCEDURE, THE NEEDLE TIP BROKE OFF AND STUCK INSIDE THE BONE, FLUSH TO THE CORTICAL SURFACE. A FRAGMENT OF 3 MM REMAINED IN THE PATIENT'S CLAVICLE. NO HANDLE WAS USED DURING THE PROCEDURE. THE PROCEDURE WAS TERMINATED ONCE IT BROKE. THE PATIENT WAS NOTIFIED AND THE NEEDLE TIP WAS NOT REMOVED SINCE THE REMOVAL OF THE FRAGMENT MIGHT DO MORE HARM THAN GOOD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 326006 | OSTYCUT DISPOSABLE BONE BIOPSY NEEDLE | DWO | ANGIOMED GMBH & CO. MEDIZINTECHNIK KG | ANWA3736 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |