MAUDE Adverse Event Report: ARTHREX, INC. SUPERMX NITI STAPLE W/ INSTRS, 20W X 15L; STAPLE, FIXATION, BONE

Model Number	SUPERMX NITI STAPLE W/ INSTRS, 20W X 15L
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
It was reported that during a metatarsal arthrodesis surgery the drill from the dynamite set is jammed in the double drill sleeve of the kit.According to the surgeon no harm for patient, operator or third party occurred.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.The complaint allegation was confirmed.One unpackaged ar-8719mxds-2015 dynanite supermx nitinol staple with instrumentation, 20w x 15l batch 2220124174 was received for investigation.The device arrived with the drill guide for investigation.Visual evaluation found scratch lines around the shaft on the laser marks.Evaluation of the drill guide noted scratch lines inside the guide holes.Functional testing was not performed due to the device being damaged.However, the critical dimensions were checked to verify any manufacturing issues.The drill bit¿s outside diameter was measured according to drawing c14636 at revision 6: diameter ø 0.120 ± 0.002, results: 0.120; diameter ø 0.104 ± 0.001, results: 0.104.Due to the damaged observed on the drill.The most likely cause of the reported and observed failure is user error, specifically applying excessive force bending the drill due to a possible misaligning the insertion.

• Brand Name: SUPERMX NITI STAPLE W/ INSTRS, 20W X 15L
• Common Device Name: STAPLE, FIXATION, BONE
• 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: 20587602
• Report Number: 1220246-2024-08372
• Device Sequence Number: 6567727
• Product Code: JDR
• UDI-Device Identifier: 00888867300897
• UDI-Public: (01)00888867300897(11)220801(17)270731(10)2220124174
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K203180
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 03/14/2025

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: SUPERMX NITI STAPLE W/ INSTRS, 20W X 15L
• Device Catalogue Number: AR-8719MXDS-2015
• Device Lot Number: 2220124174
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2024
• Supplement Date Received by Manufacturer: 02/26/2025
• Initial Report FDA Received Date: 11/01/2024
• Supplement Report FDA Received Date: 03/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2022
• 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
• Patient Sex: Unknown