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	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2021
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 unpackaged ar-8717g-03, batch 04511920 guide was received for investigation.Visual inspection identified that the guide was returned without the drill stuck inside.Inspection of each guide tunnel identified damage to the inner diameter of one particular tunnel, consistent with interference between the guide and mating instrumentation.The damage present prevented the pin from the gage set (id: (b)(4) from advancing through the tunnel.Each of the remaining guide tunnels passed the pin gage test.Based off the information provided, the most likely the result of off-axis insertion during use, and/or through prying/leveraging the drill within the guide during use.
Event or Problem Description
It was reported during a procedure the drill stopped short of the required depth for implant, and was not able to be removed from the guide during the procedure.The procedure was completed by using a disposable guide from a ds implant kit.After the case, the rep inspected the ar-8717g-03 and manually removed the drill.There is something inside the guide obstructing the drill from smoothly going through the guide.

• 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: 19562894
• Report Number: 1220246-2024-06017
• Device Sequence Number: 7704548
• Product Code: MDM
• UDI-Device Identifier: 00888867326118
• UDI-Public: 00888867326118
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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: Administrator/Supervisor
• 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, 15 / 18 MM
• Device Catalogue Number: AR-8717G-03
• Device Lot Number: 04511920
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2021
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown