MAUDE Adverse Event Report: NEXT ORTHOSURGICAL BONE TAP MIS 4.5; TAP, BONE

Model Number	CBZB005-45
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During lumbar spine surgery, a bone tap mis 4.5 mm fractured during normal use.The distal tip of the bone tap remained retained within the patient's bone and could not be retrieved intraoperatively.No patient injury, adverse clinical outcome, or additional medical or surgical intervention related to harm was reported.The device did not perform as intended.The event is considered a device malfunction with potential for serious injury if it were to recur.
Additional Manufacturer Narrative
On (b)(6) 2025, during a lumbar spine surgical procedure performed at (b)(6) hospital in (b)(6), a bone tap, mis 4.5 (catalog number cbzb005-45, lot number 002156d13), manufactured by next orthosurgical inc., was used to prepare bone for pedicle screw insertion.During the procedure, the surgeon initially used a 5.0 mm bone tap; however, bone material became lodged in the tap, preventing guide wire passage.The surgical plan was adjusted to perform sequential tapping using a 4.5 mm bone tap followed by a 6.5 mm tap prior to insertion of a 7.0 mm screw.While tapping at the l5 vertebral level using the 4.5 mm bone tap, the device fractured intraoperatively, resulting in separation of the distal tip, which remained retained within the bone.The fragment could not be removed during the procedure.No patient injury, adverse clinical outcome, or medical intervention related to device-caused harm was reported.The complaint record indicates that there have been no reported problems with the patient since the surgery.The device involved in the event was not available for return or physical evaluation, as the fractured fragment remained retained in the patient and no device sample was returned to the manufacturer.As part of the investigation, the manufacturer reviewed the device history record (dhr) for the affected lot and confirmed that the device met all inspection and release criteria.No manufacturing nonconformances were identified.The investigation also included review of images provided by the user facility and comparison with a prior similar complaint involving the same product and lot, which demonstrated similar fracture characteristics.Based on the available information, the investigation concluded that the fracture likely occurred due to external forces applied during use, with no evidence of a device design or manufacturing defect.This event is reported as a device malfunction, as recurrence of the fracture could reasonably cause or contribute to serious injury, in accordance with 21 cfr part 803.

• Brand Name: BONE TAP MIS 4.5
• Common Device Name: TAP, BONE
• Manufacturer (Section D): NEXT ORTHOSURGICAL; 3279 corporate view; suite a; vista CA 92081
• Manufacturer (Section G): NEXT ORTHOSURGICAL; 3279 corporate view; suite a; vista CA 92081
• Manufacturer Contact: yusuke nakamura ; 3270 corporate view; suite a; vista, CA 92081 ; 7602953613
• MDR Report Key: 24222175
• Report Number: 3010020754-2026-00003
• Device Sequence Number: 8196968
• Product Code: LXH
• UDI-Device Identifier: 00840314121103
• UDI-Public: (01)00840314121103(10)002156D13
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/29/2026

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 Model Number: CBZB005-45
• Device Lot Number: 002156D13
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/07/2025
• Initial Report FDA Received Date: 01/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 68 YR
• Patient Sex: Unknown
• Patient Weight: 77 KG