MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2016-02-26 for OSTYCUT BONE BIOPSY NEEDLE 17860061 manufactured by Angiomed Gmbh & Co. Medizintechnik Kg.
[39078395]
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. 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. 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 E. G. The stylet needs to be withdrawn as soon as the threaded part of the cannula obtains a grip in the bone. In case the bone biopsy cannula cannot be removed smoothly from the punctured bone area, it should not be attempted to loosen the cannula by oscillating movement, as this may lead to breakage of the cannula. 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. In section warnings it is stated: "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. " sections instructions for use states: "advance the ostycut biopsy cannula in parallel with the anaesthesia needle to the periosteum and screw the cannula into the bone wall. For reasons of safety the stylet remains within the cannula during this procedure. As soon as the threaded part of the cannula obtains a grip in the bone, hold the needle hub in place and withdraw the stylet. Continue puncture by further clockwise rotation of the ostycut biopsy cannula until the opposite internal bone wall is reached, since this enables easier detachment of the tissue cylinder. " 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 #(b)(4). The information provided by bard represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
Patient Sequence No: 1, Text Type: N, H10
[39078396]
It was reported that it was difficult to advance the bone biopsy needle into the femur of the patient. A biopsy procedure was performed on the femur of a patient with suspected chondrosarcoma. As reported by the physician it was difficult to advance the bone biopsy needle because the lesion was hard. However, the physician managed to advance the needle using the hand grip. When the needle was removed, the tip of the cannula was found missing. The doctor used another needle to complete the procedure accessing from another direction. A needle of the same brand and type with a length of 75 mm was used. As reported, it was found later that the tissue obtained was not enough to confirm the diagnosis. As a result, an incision biopsy is scheduled to be performed. The retained cannula tip will be removed at that time. There has been no further patient injury reported to date.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9681442-2016-00057 |
| MDR Report Key | 5462613 |
| Report Source | DISTRIBUTOR |
| Date Received | 2016-02-26 |
| Date of Report | 2016-01-28 |
| Date of Event | 2016-01-15 |
| Date Mfgr Received | 2016-01-28 |
| Device Manufacturer Date | 2015-04-14 |
| Date Added to Maude | 2016-02-26 |
| 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 | FRANK KIRCHNER |
| 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 | 2016-02-26 |
| Returned To Mfg | 2016-02-05 |
| Catalog Number | 17860061 |
| Lot Number | ANZC2462 |
| Device Expiration Date | 2018-03-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2016-02-26 |