MAUDE Adverse Event Report: SURGENTEC, LLC BMAN SOLID DIAMOND NEEDLE; INSTRUMENT, BIOPSY

Catalog Number	AAN-09-BMANS
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Rep stated that the doctor impacted the b-man into the cortical bone of the iliac crest to pierce the cortex.He continued with the aspiration procedure and when he removed the needle, he noticed that the tip was not attached to the b-man cannula.They took an x-ray and determined it remained in the ilium.The rep expressed that the doctor did not strike the instrument excessively and did not use excessive force while working with the instrument.Rep also stated that this did not cause the patient to stay under anesthesia longer than originally anticipated.

• Brand Name: BMAN SOLID DIAMOND NEEDLE
• Common Device Name: INSTRUMENT, BIOPSY
• Manufacturer (Section D): SURGENTEC, LLC; 911 clint moore rd; boca raton
• Manufacturer (Section G): SURGENTEC, LLC; 911 clint moore rd; boca raton FL 33487
• Manufacturer Contact: guilherme pires ; 911 clint moore rd; boca raton 33487 ; 5619907882
• MDR Report Key: 24630079
• Report Number: 3012495575-2026-00001
• Device Sequence Number: 9068771
• Product Code: KNW
• UDI-Device Identifier: 00810131880941
• UDI-Public: 00810131880941
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K240664
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/03/2026

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 Catalogue Number: AAN-09-BMANS
• Device Lot Number: 26SUR0027
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/03/2026
• Initial Report FDA Received Date: 03/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown