MAUDE Adverse Event Report: ARTHREX, INC. BONE TAP, CANNULATED, 4.5MM; ORTHOPEDIC MANUAL SURG INSTR

Model Number	BONE TAP, CANNULATED, 4.5MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
On 5/9/2024, a sales representative reported via (b)(4) that an ar-8956c-45t bone tap, cannulated, 4.5 mm, broke during a 5th metatarsal fracture.When the surgeon turned the ar-8956c-45t bone tap counterclockwise, it broke, snapping the entire "gold" portion of the tap in the shaft of the metatarsal.They were able to get it out with a non-arthrex hardware removal set.This was discovered during a metatarsal fracture procedure, with no reported patient harm.Additional information was received on 5/20/2024: all broken pieces were retrieved from the patient.The case was delayed 25 minutes to retrieve the end of the tap from the canal of the 5th metatarsal.The patient had to have longer or time, more anesthesia, and a larger incision.
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Based on the information provided, which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to misaligned insertion or prying/leveraging the device during insertion.

• Brand Name: BONE TAP, CANNULATED, 4.5MM
• Common Device Name: ORTHOPEDIC MANUAL SURG INSTR
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: jared engle ; 8009337001
• MDR Report Key: 19475865
• Report Number: 1220246-2024-05028
• Device Sequence Number: 6932823
• Product Code: LXH
• UDI-Device Identifier: 00888867055728
• UDI-Public: 00888867055728
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: BONE TAP, CANNULATED, 4.5MM
• Device Catalogue Number: AR-8956C-45T
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 06/05/2025
• Initial Report FDA Received Date: 06/06/2024
• Supplement Report FDA Received Date: 06/25/2025
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown