MAUDE Adverse Event Report: ARTHREX, INC. IMPLSYS 2NDRY FIXATN BIOSWVLK 4.75X19.1; BIO SOFT TISSUE FIXATN FASTNR

Model Number	IMPLSYS 2NDRY FIXATN BIOSWVLK 4.75X19.1
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/18/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the handle disengaged from the tap during use.They used another tap to complete the case.
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 device was not received for evaluation.Based off the information provided, the most likely cause for the reported failure can be attributed to misuse of the device due to damage to the device.

• Brand Name: IMPLSYS 2NDRY FIXATN BIOSWVLK 4.75X19.1
• Common Device Name: BIO SOFT TISSUE FIXATN FASTNR
• 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: 19311899
• Report Number: 1220246-2024-03247
• Device Sequence Number: 2972367
• Product Code: MAI
• UDI-Device Identifier: 00888867331310
• UDI-Public: 00888867331310
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K151342
• 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): 05/14/2024

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 Expiration Date: 02/29/2024
• Device Model Number: IMPLSYS 2NDRY FIXATN BIOSWVLK 4.75X19.1
• Device Catalogue Number: AR-1593-BC
• Device Lot Number: 11100723
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2021
• Initial Report FDA Received Date: 05/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/15/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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
• Patient Sex: Unknown