MAUDE Adverse Event Report: ANGIOMED GMBH & CO. MEDIZINTECHNIK KG OSTYCUT DISPOSABLE BONE BIOPSY NEEDLES; BONE INSTRUMENT

Model Number	17820050
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a bone biopsy procedure of the right calcaneum, the biopsy material allegedly remained in the bone during removal.There was no reported patient injury.
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records 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 bd 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 bd.
Additional Manufacturer Narrative
H10: manufacturing review: the lot history records of this lot were reviewed with special attention to the manufacturing and inspection of this product and the product was found to have met the specification prior to shipment.Investigation summary: the sample was not returned for evaluation.Based on the information available and as no sample was returned, the investigation is inconclusive for reported issue.A definitive root cause for the reported issue could not be determined.Labeling review: in reviewing the labeling supplied with this product, it was found that the instructions for use sufficiently addresses the potential risks during use of the device.With regards to warnings, the instructions for use 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 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".The instructions for use equally states that "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".H10: b5, d4 (expiration date: 10/2022), g3.H11: h6(device).H11: section a through f - the information provided by bd 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 bd.H3 other text : device not returned.
Event or Problem Description
It was reported that during a bone biopsy procedure of the right calcaneum, the biopsy material allegedly remained in the bone during removal.Detached segment of the material that remained in the patient's calcaneus.There was no reported patient injury.

• Brand Name: OSTYCUT DISPOSABLE BONE BIOPSY NEEDLES
• Common Device Name: BONE INSTRUMENT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstr. 6; karlsruhe 76227 ; GM 76227
• Manufacturer (Section G): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstr. 6; karlsruhe 76227 ; GM 76227
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 14600219
• Report Number: 9681442-2022-00174
• Device Sequence Number: 17678953
• Product Code: GAA
• UDI-Device Identifier: 00801741083679
• UDI-Public: (01)00801741083679
• Combination Product (Y/N): N
• Initial Reporter Country: MB
• PMA/510(K) Number: UNKNOWN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2022

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 Model Number: 17820050
• Device Catalogue Number: 17820050
• Device Lot Number: ANDX1703
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/16/2022
• Supplement Date Received by Manufacturer: 08/18/2022
• Initial Report FDA Received Date: 06/06/2022
• Supplement Report FDA Received Date: 08/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown