MAUDE Adverse Event Report: ARTHREX, INC. DYNANITE NITI STAPLE W/INSTRS 9WX7L; STAPLE, FIXATION, BONE

Model Number	DYNANITE NITI STAPLE W/INSTRS 9WX7L
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During returned device evaluation, a reportable malfunction was discovered.The complaint is confirmed.(1) drill guide, (1) drill bit, and (2) staple alignment pins were received for evaluation.All devices were received unpackaged.Visual evaluation of the staple alignment pins found no apparent issues.Visual evaluation of the drill bit identified several deep circumferential abrasion marks on the drill bit shoulder, indicating interference with the drill guide tubes during use.The tip of the drill was worn/dull, indicating impact with a hard surface during use, such as another metallic device.Visual evaluation of the drill guide identified deep circumferential scratches in the inner diameter of the drill guide tubes, indicating interference with the drill bit during use.The right tube had significant damage to the internal walls.Upon insertion of the drill bit into the drill guide tubes, it was noted that the drill bit could go through the left tube, but not through the right tube.While the direct cause for the damage found can be attributed to the interference between the two devices, the original condition of the devices prior to use cannot be assessed, and no evidence was found of a pre-existing material deformity prior to use.Therefore, the root cause of the damage and interference identified remains undetermined.A potential cause could be attributed to activating the drill while the drill bit tip is being inserted into the drill guide, damaging the tip and scratching the inner wall of the drill guide, creating the interference between the two devices and subsequently extending the damage to both devices by continuous usage.
Event or Problem Description
It was reported on 10/19/2022 by a arthrex employee via sems that an ar-8717ds-0907 staple implant system would not drill because of interference with the drill guide.This was discovered during a case with no patient harm.During returned device evaluation, a reportable malfunction was discovered.

• Brand Name: DYNANITE NITI STAPLE W/INSTRS 9WX7L
• 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: vik bajnath ; 8009337001
• MDR Report Key: 16087327
• Report Number: 1220246-2023-06028
• Device Sequence Number: 20465350
• Product Code: JDR
• UDI-Device Identifier: 00888867287846
• UDI-Public: 00888867287846
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K203180
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 01/03/2023

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 Expiration Date: 01/31/2026
• Device Model Number: DYNANITE NITI STAPLE W/INSTRS 9WX7L
• Device Catalogue Number: AR-8717DS-0907
• Device Lot Number: 1019109476
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2022
• Initial Report FDA Received Date: 01/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown