MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2015-06-17 for OSTYCUT BONE BIOPSY NEEDLE 17860061 manufactured by Angiomed Gmbh & Co. Medizintechnik Kg.
[21084790]
It was reported that during a biopsy of the ilium, difficulties in advancing the bone biopsy needle into the hard bone tissue were experienced. Therefore, the device was removed. After removal, the distal tip of the outer cannula was found to be broken off and remaining in the bone tissue. It was decided to leave the fragment in the patient's ilium. The patient was discarded from hospital and is being monitored. No further patient injury was reported.
Patient Sequence No: 1, Text Type: D, B5
[21377085]
The lot history records have been reviewed with special attention to the manufacturing and inspection of this product and the product was found to have met all specifications prior to shipment. There is no indication for a manufacturing-related failure. The evaluation of the returned device and images confirmed the fracture of the distal part of the outer cannula. The fragment remained in the patient's bone. The cannula was found to be bent. Potential factors that could have led or contributed to the event have been evaluated. Previous investigations of similar complaints have been reviewed. This kind of event may be associated with improper handling of the cannula during advancement into and/or during removal from the bone. The condition of the cannula indicates the application of high force leading to the reported fracture. Hard bone tissue may lead to biopsy difficulties resulting in a damage of the needle. On the basis of the information available, a definite root cause could not be determined. The ifu supplied with this device sufficiently describes the correct application of the biopsy needle.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9681442-2015-00070 |
| MDR Report Key | 4855506 |
| Report Source | 08 |
| Date Received | 2015-06-17 |
| Date of Report | 2015-05-20 |
| Date of Event | 2015-05-13 |
| Date Mfgr Received | 2015-05-20 |
| Device Manufacturer Date | 2014-09-01 |
| Date Added to Maude | 2015-06-22 |
| 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 | DANIELLA MUELLER |
| 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 BONE BIOPSY NEEDLE |
| Generic Name | DWO |
| Product Code | DWO |
| Date Received | 2015-06-17 |
| Returned To Mfg | 2015-05-28 |
| Catalog Number | 17860061 |
| Lot Number | ANYH0827 |
| Device Expiration Date | 2017-08-31 |
| 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 | KARLSRUHE GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2015-06-17 |