MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2011-05-23 for OSTYCUT DISPOSABLE BONE BIOPSY NEEDLE 17860060 manufactured by Angiomed Gmbh & Co. Medizintechnik.
[2121544]
It was reported in a user facility medwatch report that during a bone biopsy procedure of the patient's first right metatarsal, while the device was being removed after the second sample, 2mm of the tip of the biopsy needle broke off in the bone. Reportedly, the detached tip was successfully removed during a previously scheduled i & d procedure which was scheduled for the following day. There was no reported patient injury.
Patient Sequence No: 1, Text Type: D, B5
[9281914]
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. Based on the results of the manufacturing review, no indication for a manufacturing related cause could be identified. The investigation is currently underway. Note: this event is associated with uf report number: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9681442-2011-00025 |
| MDR Report Key | 2158771 |
| Report Source | 06 |
| Date Received | 2011-05-23 |
| Date of Report | 2011-04-26 |
| Date Mfgr Received | 2011-04-26 |
| Device Manufacturer Date | 2010-12-01 |
| Date Added to Maude | 2011-07-18 |
| 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 | JESSICA WILLIAMS |
| Manufacturer Street | 1625 WEST 3RD STREET |
| Manufacturer City | TEMPE AZ 85281 |
| Manufacturer Country | US |
| Manufacturer Postal | 85281 |
| Manufacturer Phone | 4808949515 |
| 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 DISPOSABLE BONE BIOPSY NEEDLE |
| Product Code | DWO |
| Date Received | 2011-05-23 |
| Catalog Number | 17860060 |
| Lot Number | ANUK1877 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ANGIOMED GMBH & CO. MEDIZINTECHNIK |
| Manufacturer Address | KARLSRUHE GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-05-23 |