MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2016-02-12 for OSTYCUT BONE BIOPSY NEEDLE 17820021 manufactured by Angiomed Gmbh & Co. Medizintechnik Kg.
[38083736]
The device history records are being reviewed. The event is currently under investigation.
Patient Sequence No: 1, Text Type: N, H10
[38083737]
It was reported that during a bone biopsy procedure for determination of a possible metastatic tumor of the fifth dorsal vertebra, upon retraction of the cannula after a specimen was obtained the tip of the cannula was found to be broken off with the fragment remaining in the patient's bone. It was determined that the fragment would not cause any health hazard to the patient and therefore, no attempt was made to retrieve the broken segment. No further patient injury was reported.
Patient Sequence No: 1, Text Type: D, B5
[42545816]
As the lot number of the subject device has not been provided, a device history record review could not be performed. During the evaluation of the returned device, the distal end of the cannula was found to be broken off. The fracture site was located at the thread. No indication for a material or manufacturing related failure was found. Potential factors that could have led or contributed to the reported event have been considered. Previous investigations of similar complaints have been reviewed. This type of event may be associated with improper handling of the biopsy cannula during advancement into the bone as well as during removal from the bone. Oscillating movements of the cannula may lead to this kind of breakage. On the basis of the information available, 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: "advance the ostycut biopsy cannula (... ) to the periosteum and screw the cannula into the bone wall. For reasons of safety the stylet remains within the cannula during this procedure. In case the ostycut biopsy cannula cannot be removed smoothly from the punctured bone area, do not attempt to loosen the ostycut biopsy cannula by oscillating movement of the cannula. Instead, it is advised to loosen and remove the ostycut biopsy cannula from the punctured bone area by simultaneously applying counterclockwise rotation and traction. "
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9681442-2016-00046 |
| MDR Report Key | 5432879 |
| Report Source | DISTRIBUTOR |
| Date Received | 2016-02-12 |
| Date of Report | 2016-01-15 |
| Date of Event | 2016-01-06 |
| Date Mfgr Received | 2016-03-18 |
| Date Added to Maude | 2016-02-12 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | DANIELA MUELLER |
| Manufacturer Street | WACHHAUSSTRASSE 6 |
| Manufacturer City | KARLSRUHE 76227 |
| Manufacturer Country | GM |
| Manufacturer Postal | 76227 |
| Manufacturer Phone | 0497219445 |
| Manufacturer G1 | ANGIOMED GMBH & CO. MEDIZINTECHNIK KG -9681442 |
| 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 BONE BIOPSY NEEDLE |
| Generic Name | BONE BIOPSY NEEDLE |
| Product Code | DWO |
| Date Received | 2016-02-12 |
| Returned To Mfg | 2016-01-26 |
| Catalog Number | 17820021 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ANGIOMED GMBH & CO. MEDIZINTECHNIK KG |
| Manufacturer Address | WACHHAUSSTRASSE 6 KARLSRUHE 76227 GM 76227 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2016-02-12 |