MAUDE Adverse Event Report: ARTHREX, INC. PUNCH/TAP 4.75MM BC CORKSCREW; ORTHOPEDIC MANUAL SURG INSTR

Model Number	PUNCH/TAP 4.75MM BC CORKSCREW
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 14 august 2024, it was reported by a sales representative via email that an ar-1927ptb-475 punch/tap 4.75mm bc corkscrew was reported to have bent during use.This occurred on 06 august 2024 in (b)(6) hospital during a rotator cuff repair.When using the device the tip bent to a 90 degree angle, the tip did not break off in the patient but after this occurred it could not be used again.The case was completed successfully using the same device.The bent device was removed successfully and the anchor was inserted without any complications.There was case involvement.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
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 user error of the device due to excessive force being used during insertion of the implant.

• Brand Name: PUNCH/TAP 4.75MM BC CORKSCREW
• 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: 20140263
• Report Number: 1220246-2024-07364
• Device Sequence Number: 15307824
• Product Code: LXH
• UDI-Device Identifier: 00888867239173
• UDI-Public: 00888867239173
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2025

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: PUNCH/TAP 4.75MM BC CORKSCREW
• Device Catalogue Number: AR-1927PTB-475
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/09/2024
• Supplement Date Received by Manufacturer: 06/09/2025
• Initial Report FDA Received Date: 09/04/2024
• Supplement Report FDA Received Date: 06/24/2025
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown