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

Model Number	BONE TAP, CORTICAL
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.Arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.Complaint confirmed.One unpackaged ar-13437, batch 562002 tap was returned for investigation.Visual inspection as well attempts at functional testing identified that the tap was lodged within the ar-13438, batch 561240 handle and could not be disengaged.As such, the inner diameter of the handle's mating feature could not be analyzed.No damage was noted to the visible end of the ar-13437.The most likely cause for the reported failure can be attributed to user error of the device due to prying/leveraging the device during insertion.
Event or Problem Description
It was reported that after a high tibial osteotomy procedure, the facility could not get the bone tap to disengage from the handle.

• Brand Name: BONE TAP, CORTICAL
• 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: 19286313
• Report Number: 1220246-2024-03088
• Device Sequence Number: 8360800
• Product Code: LXH
• UDI-Device Identifier: 00888867013117
• UDI-Public: 00888867013117
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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
• Report Date (Section B): 05/10/2024

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: BONE TAP, CORTICAL
• Device Catalogue Number: AR-13437
• Device Lot Number: 562002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2021
• Initial Report FDA Received Date: 05/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/18/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown