MAUDE Adverse Event Report: ARTHREX, INC. DYNANITE® STAPLE DRILL GUIDE, 20 / 25 MM; MANUAL INSTR, GENERAL SURGICAL

Model Number	DYNANITE® STAPLE DRILL GUIDE, 20 / 25 MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2022
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.The complaint is confirmed.(1) unpackaged ar-8717g-04 was received for evaluation.Visual inspection noted the tip of one of the 20mm-spaced drill guides was deformed and its surface was blackened.A.126 inch pin fit through the undeformed inner diameter of all (4) drill guides, indicating the device is within the inner diameter specification of.127 +-.002 inch.The allegation of "too tight" is not confirmed, although the damage to the drill guide tip will deform the inner diameter and impede full insertion of the drill.The damage identified in the device indicates a collision between the drill guide and the drill during use.The cause of this event can be characterized as user error.
Event or Problem Description
On 7/25/2022, it was reported by a sales representative via sems that an ar-8717g-04 dynanite staple parallel drill guide was bent at the end and to tight during drilling.This was discovered during an unspecified procedure, patient was not affected.

• Brand Name: DYNANITE® STAPLE DRILL GUIDE, 20 / 25 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: 19318969
• Report Number: 1220246-2024-03295
• Device Sequence Number: 6319992
• Product Code: MDM
• UDI-Device Identifier: 00888867326125
• UDI-Public: 00888867326125
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/15/2024

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, 20 / 25 MM
• Device Catalogue Number: AR-8717G-04
• Device Lot Number: 04512005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2022
• Initial Report FDA Received Date: 05/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/05/2020
• 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