MAUDE Adverse Event Report: ARTHREX, INC. DYNANITE¿ STAPLE DRILL GUIDE, 9 / 11 MM; MANUAL INSTR, GENERAL SURGICAL

Model Number	DYNANITE¿ STAPLE DRILL GUIDE, 9 / 11 MM
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/27/2021
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 not confirmed, the devices were returned disassembled and met dimensional specifications.Circumferential abrasion damage was however observed on the od of the drill bit and id of one of the guides.Based off the information provided, the most likely cause for the reported failure can be attributed to user error of the device due to prying/leveraging the device during use.
Event or Problem Description
It was reported during an akin procedure while drilling the first pilot hole for a 9 x 10 staple the ar-8717d-01 1.6 drill got stuck in the ar-8717g-01 guide.The rep stated nothing could be done while in or to free it from the guide (mallet and pliers were attempted among other things).It was like the instruments had ¿cold fused¿ together.It was not until the instruments were still hot from the washer that the rep was able to separate them.You can see from inspection that there is damage to the drill and inside of the drill guide.The drill will not slide freely through the one side.This is the a new set at this facility and the first time used in case.The case was completed by opening a staple kit (ar-8717ds-0910 / lot: 0295107266) in order to complete drilling for the already opened staple only kit.

• Brand Name: DYNANITE¿ STAPLE DRILL GUIDE, 9 / 11 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: 19561771
• Report Number: 1220246-2024-05998
• Device Sequence Number: 7483278
• Product Code: MDM
• UDI-Device Identifier: 00888867326095
• UDI-Public: 00888867326095
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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): 06/18/2024

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, 9 / 11 MM
• Device Catalogue Number: AR-8717G-01
• Device Lot Number: 032007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/27/2021
• Initial Report FDA Received Date: 06/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown