MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-09-07 for OSTYCUT BONE BIOPSY NEEDLE 17800050 manufactured by Angiomed Gmbh & Co. Medizintechnik Kg.
[25106082]
The investigation is currently underway. 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
[25106083]
It was reported that the tip of the bone biopsy needle broke off inside the patient's bone. Therefore, the doctor had to retrieve the broken tip.
Patient Sequence No: 1, Text Type: D, B5
[32145142]
The lot number of the subject device has not been provided; therefore, a device history record review could not be performed. The evaluation of the returned device confirmed the detachment of the cannula from the hub. Although it was reported that the tip was broken off in the bone, the threaded tip of the cannula was found to be undamaged. No indication for an insufficient adhesive application was found. On the basis of the condition of the sample, there is no indication that a material or manufacturing related failure might have caused the defect. 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 device either during advancement into the bone or during removal from the bone. 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: "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 movements 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 | 9681442-2015-00149 |
| MDR Report Key | 5059613 |
| Date Received | 2015-09-07 |
| Date of Report | 2015-08-11 |
| Date of Event | 2015-08-05 |
| Date Mfgr Received | 2015-09-22 |
| Date Added to Maude | 2015-09-07 |
| 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 | 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 | 2015-09-07 |
| Returned To Mfg | 2015-08-20 |
| Catalog Number | 17800050 |
| 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. Required No Informationntervention | 2015-09-07 |