MAUDE Adverse Event Report: ARTHREX, INC. BIO-COMPRESSION CANN DILATOR TAP, 16MM; ORTHOPEDIC MANUAL SURG INSTR

Model Number	BIO-COMPRESSION CANN DILATOR TAP, 16MM
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2021
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.The complaint is not confirmed.One unpackaged ar-5025tbc-16, batch 031724 was received for investigation.Visual inspection concluded without the observance of any damage or abnormalities.No problem found.
Event or Problem Description
It was reported that the device is not going through anymore.There was no harm or adverse event for patient, operator or third party reported.No further information received.

• Brand Name: BIO-COMPRESSION CANN DILATOR TAP, 16MM
• 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: 19212921
• Report Number: 1220246-2024-02618
• Device Sequence Number: 6942158
• Product Code: LXH
• UDI-Device Identifier: 00888867034860
• UDI-Public: 00888867034860
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/30/2024

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: BIO-COMPRESSION CANN DILATOR TAP, 16MM
• Device Catalogue Number: AR-5025TBC-16
• Device Lot Number: 031724
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2021
• Initial Report FDA Received Date: 04/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/20/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown