MAUDE Adverse Event Report: ARTHREX, INC. DYNANITE® STAPLE DRILL GUIDE, 15 / 18 MM; MANUAL INSTR, GENERAL SURGICAL

Model Number	DYNANITE® STAPLE DRILL GUIDE, 15 / 18 MM
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2021
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.One of the four drill holes will not allow the mating drill bit to pass through.Visual inspection with a microscope revealed damage along the inner diameter of the drill hole.The id had a rough texture likely the result of metal on metal grinding with the drill bit.The cause of the obstruction is unclear, although compacted human tissue along the id could have been responsible.The most likely cause for the reported failure can be attributed to misuse due to user error of the device due to excessive force being used.
Event or Problem Description
It was reported that when the doctor drilled using an ar-8717g-03 drill guide and ar-8717d-03-ru drill bit, the thick part and sleeve locked on the drill shaft and it would not move.Bone fragments were removed, but the problem of the thick part of the drill shaft not being able to pass through, was not resolved.A new product was used and the case was completed.No adverse effect to the patient reported.

• Brand Name: DYNANITE® STAPLE DRILL GUIDE, 15 / 18 MM
• 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: 19333164
• Report Number: 1220246-2024-03423
• Device Sequence Number: 3101944
• Product Code: MDM
• UDI-Device Identifier: 00888867326118
• UDI-Public: 00888867326118
• 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): 05/16/2024

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: DYNANITE® STAPLE DRILL GUIDE, 15 / 18 MM
• Device Catalogue Number: AR-8717G-03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2021
• Initial Report FDA Received Date: 05/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown