MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2013-07-15 for OSTYCUT DISPOSABLE BONE BIOPSY NEEDLE 17840010 manufactured by Angiomed Gmbh & Co. Medizintechnik Kg.
[3577459]
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.
Patient Sequence No: 1, Text Type: D, B5
[10901521]
The investigation is currently underway.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9681442-2013-00076 |
| MDR Report Key | 3231790 |
| Report Source | 07 |
| Date Received | 2013-07-15 |
| Date of Report | 2013-06-19 |
| Date Mfgr Received | 2013-06-19 |
| Device Manufacturer Date | 2012-02-01 |
| Date Added to Maude | 2013-10-07 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | FRANK KIRCHNER |
| Manufacturer Street | WACHHAUSSTRASSE 6 |
| Manufacturer City | KARLSRUHE 76227 |
| Manufacturer Country | GM |
| Manufacturer Postal | 76227 |
| Manufacturer Phone | 2194450 |
| Manufacturer G1 | ANGIOMED GMBH & CO. MEDIZINTECHNIK KG |
| Manufacturer Street | WACHHAUSSTRASSE 6 |
| Manufacturer City | KARLSRUHE 76227 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 76227 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OSTYCUT DISPOSABLE BONE BIOPSY NEEDLE |
| Product Code | DWO |
| Date Received | 2013-07-15 |
| Catalog Number | 17840010 |
| Lot Number | ANWA3736 |
| Device Expiration Date | 2015-01-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ANGIOMED GMBH & CO. MEDIZINTECHNIK KG |
| Manufacturer Address | KARLSRUHE GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-07-15 |