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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2021
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, the tip of the device is bent.The laser mark is also discolored, and the handle is bent.The gouges at the proximal end indicate the device was impacted.A likely cause of the bent tip is user-applied mechanical forces.
Event or Problem Description
It was reported during a rotator cuff the punch bent while punching into the bone.It was used to complete the process and the case was completed with no further issues.No patient injury or adverse effect.

• 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: 19165688
• Report Number: 1220246-2024-02264
• Device Sequence Number: 20797253
• Product Code: LXH
• UDI-Device Identifier: 00888867239173
• UDI-Public: 00888867239173
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 04/23/2024

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: PUNCH/TAP 4.75MM BC CORKSCREW
• Device Catalogue Number: AR-1927PTB-475
• Device Lot Number: 011901
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2021
• Initial Report FDA Received Date: 04/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/10/2019
• 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