MAUDE Adverse Event Report: ARTHREX, INC. 2.4MM BIO-SUTURETAK DISPOSABLES KIT; MANUAL INSTR, GENERAL SURGICAL

Model Number	2.4MM BIO-SUTURETAK DISPOSABLES KIT
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2021
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.Visual evaluation confirms the 2.4 mm drill is stuck inside the spear shaft.The drill appears to have bottomed out and the ring at the proximal end is in contact with the proximal end of the blue handle.The drill bit could not be removed from the shaft.Heavy damage can be observed at the proximal end of the drill bit.The drill bit is protruding about 3 mm from the distal end of the spear.No dimensions could be recorded due to the damage observed.Circumferential grinding marks were observed on the drill bit.The most likely cause for the reported failure can be attributed to improper bone prep; misaligned insertion; prying/leveraging the device during insertion.
Event or Problem Description
It was reported that after using the ar-1934-24ds the drill bit could not be removed from the drill guide.No adverse effect to the patient reported.

• Brand Name: 2.4MM BIO-SUTURETAK DISPOSABLES KIT
• Common Device Name: MANUAL INSTR, GENERAL SURGICAL
• 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: 19567099
• Report Number: 1220246-2024-06107
• Device Sequence Number: 6962901
• Product Code: MDM
• UDI-Device Identifier: 00888867023864
• UDI-Public: 00888867023864
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 06/19/2024

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: 2.4MM BIO-SUTURETAK DISPOSABLES KIT
• Device Catalogue Number: AR-1934-24DS
• Device Lot Number: 11482585
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2021
• Initial Report FDA Received Date: 06/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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