MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-12-10 for OSTYCUT BONE BIOPSY NEEDLE 17860061 manufactured by Angiomed Gmbh & Co. Medizintechnik Kg.
[33248238]
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 further patient details.
Patient Sequence No: 1, Text Type: N, H10
[33248239]
It was reported that the tip of the bone biopsy needle broke off while advancing the cannula into the left femur. The broken part remained in the bone. No intervention was performed; it was decided to leave the fragment in the bone. Note: as reported, the bone biopsy procedure was performed twice and the same event occured with another device. This is the same patient as reported in medwatch report # 9681442-2015-00243.
Patient Sequence No: 1, Text Type: D, B5
[39020410]
The lot 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. No manufacturing anomalies or changes which may have caused or contributed to the reported event have been identified. The cannula was returned for evaluation. The distal end of the cannula was found to be broken off. The break off site was located at the thread. The cannula was slightly bent; however, no indication of any device damage caused by improper use by the customer could be found. No indication of a material or manufacturing related cause could be identified. Potential product and non product related factors that could have led to the reported event have been considered. Previous investigation results of similar complaints have been reviewed to determine the root cause. This type of event may be associated with improper handling during advancement of the biopsy cannula into the bone as well as during removal of the cannula. E. G. Oscillating movement of the cannula may have led to the breakage. In this case it was reported that a hammer was used during the procedure. However, based on the sample evaluation no indication of any device damage caused by improper use by the customer could be identified. Based on the information available and the evaluation of the sample a definite root cause for the reported event could not be determined. In reviewing the labeling supplied with this product it was found that the instructions for use (ifu) sufficiently describe the correct application of the product. 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. " although this product was not sold in the u. S. , this event is being reported under regulation 21cfr part 803 as it involves a similar device to a device market in the u. S. Under #k874585.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9681442-2015-00242 |
| MDR Report Key | 5284576 |
| Date Received | 2015-12-10 |
| Date of Report | 2015-11-11 |
| Date of Event | 2015-11-11 |
| Date Mfgr Received | 2016-01-27 |
| Device Manufacturer Date | 2015-06-29 |
| Date Added to Maude | 2015-12-10 |
| 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 | 2015-12-10 |
| Returned To Mfg | 2015-12-04 |
| Catalog Number | 17860061 |
| Lot Number | ANZE1684 |
| Device Expiration Date | 2018-05-31 |
| 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 | WACHHAUSSTRASSE 6 KARLSRUHE 76227 GM 76227 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2015-12-10 |