MAUDE Adverse Event Report: ANGIOMED GMBH & CO. MEDIZINTECHNIK KG OSTYCUT BONE BIOPSY NEEDLE

Model Number	17860070
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/17/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a manufacturing review will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.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.
Event or Problem Description
It was reported that approximately two millimeters of the beveled needle tip allegedly fractured within the patient as the device was being removed.This occurred during a ct-guided rib biopsy.It was further reported that there was no attempt to retrieve the detached tip.The bone sample was obtained and the procedure was completed.There was no reported patient injury.
Event or Problem Description
It was reported that approximately two millimeters of the beveled needle tip allegedly fractured within the patient as the device was being removed.This occurred during a ct-guided rib biopsy.It was further reported that there was no attempt to retrieve the detached tip.The bone sample was obtained and the procedure was completed.There was no reported patient injury.
Additional Manufacturer Narrative
After further review of the details provided by the complainant, it was identified that the fda rn number was incorrect and the correct fda rn number is 9681442.This number will not be changed on the emdr so that this report will remain connected and identify that the event was reported to the fda in a timely manner.As the lot number for the device was provided, a manufacturing review will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.

• Brand Name: OSTYCUT BONE BIOPSY NEEDLE
• Common Device Name: BONE BIOPSY NEEDLE
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• MDR Report Key: 7546044
• Report Number: 2020394-2018-00735
• Device Sequence Number: 11248208
• Product Code: DWO
• UDI-Device Identifier: 00801741083792
• UDI-Public: (01)00801741083792
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K874585
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/07/2019
• Device Model Number: 17860070
• Device Catalogue Number: 17860070
• Device Lot Number: ANAX0820
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/01/2018
• Supplement Date Received by Manufacturer: 05/01/2019
• Initial Report FDA Received Date: 05/25/2018
• Supplement Report FDA Received Date: 05/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 52 YR