MAUDE Adverse Event Report: ARTELON DRILL BIT CANNULATED DRILL BIT 4.50 MM; BIT, DRILL

Catalog Number	61015
Medical Device Problem Code	Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/18/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This case is part of a remediation performed by stryker following the acquisition of artelon company.This case has already concluded with minimal information.Therefore, no supplemental mdr will be submitted unless additional information is provided.This investigation is part of the artelon remediation aiming to transfer the data history into tw.An investigation of this case has already been performed by artelon.The conclusion of the investigation states: feedback received on 4.5mm drill bit.User did not have 5.0mm anchors, as recommended when using 4.5mm drill bit.
Event or Problem Description
It was reported in a procedure involving a 32-year-old male patient, a 4.5 drill bit was successfully used on the talus.However, when used on the fibula, the anchor pulled out due to softer bone in that area.A 4.25 drill was used to create a new hole in a different location, which worked great.
Event or Problem Description
It was reported in a procedure involving a 32-year-old male patient, a 4.5 drill bit was successfully used on the talus.However, when used on the fibula, the anchor pulled out due to softer bone in that area.A 4.25 drill was used to create a new hole in a different location, which worked great.
Additional Manufacturer Narrative
Correction to h6 (results code and conclusion code) and d4 (catalog # and lot #).

• Brand Name: DRILL BIT CANNULATED DRILL BIT 4.50 MM
• Common Device Name: BIT, DRILL
• Manufacturer (Section D): ARTELON; 8601 dunwoody place; suite 250; sandy springs GA 30350
• Manufacturer (Section G): ARTELON; 8601 dunwoody place; suite 250; sandy springs GA 30350
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 20938856
• Report Number: 3010673515-2024-00001
• Device Sequence Number: 8135690
• Product Code: HTW
• UDI-Device Identifier: 00850003396279
• UDI-Public: 00850003396279
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/18/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 61015
• Device Lot Number: R51001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/18/2024
• Supplement Date Received by Manufacturer: 01/22/2025
• Initial Report FDA Received Date: 12/16/2024
• Supplement Report FDA Received Date: 02/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown