MAUDE Adverse Event Report: SPINECRAFT ASTRA SPINE SYSTEM; BONE TAP

Catalog Number	6300-71-45-NC
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/17/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The review of the device history record was performed for applicable material, manufacturing processes, design specifications and inspection records.No deviations or discrepancies were found that could have contributed to the reported issue.Furthermore, the usage history review showed this lot has been in use in various surgical sterilization kits for several years with no similar complaints reported previously.Per spinecraft instruction for use, reusable instruments are required to be inspected carefully prior to each surgery and particularly the edges for those instruments with cutting features must be checked for distortion/large nicks.That said, based on the nature of the incident and information collected, we can only speculate that this failure is a result of normal wear and tear.
Event or Problem Description
The tip of the ø4.5mm tap broke during use.Surgery was completed successfully with another available tap with no patient complications reported.

• Brand Name: ASTRA SPINE SYSTEM
• Common Device Name: BONE TAP
• Manufacturer (Section D): SPINECRAFT; 777 oakmont lane, suite # 200; westmont 60559 5511
• Manufacturer Contact: ami akallal-asaad ; 777 oakmont lane, suite # 200; westmont, IL 60559-5511 ; 6309207300
• MDR Report Key: 24720467
• Report Number: 3004717358-2026-00001
• Device Sequence Number: 6088280
• Product Code: LXH
• UDI-Device Identifier: 00193082076480
• UDI-Public: (01)00193082076480(10)PM042714
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 03/27/2026

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: 6300-71-45-NC
• Device Lot Number: PM042714
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2026
• Initial Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/10/2015
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Male