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

Model Number DYNANITE NITI STAPLE W/INSTRS 9WX7L

Device Problems Connection Problem (2900); Mechanical Jam (2983)

Patient Problems Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/07/2022

Event Type  malfunction  

Event Description

On 9/7/2022, it was reported by a sales rep via email that a ar-8717ds-0907, dynanite niti staple w/instrs 9wx7l, was reported that on the first pass of the drill bit, it became stuck in the drill guide.It can rotate but can not be extracted.This was discovered during a 1st metatarsal cheilectomy and akin osteotomy.The patient was involved.To complete the procedure, a 1.6mm k-wire was used to prepare the hole for the dynanite staple second leg.

Manufacturer Narrative

The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.

Manufacturer Narrative

The complaint is confirmed based on the customer provided photo, which displays the blocked drill bit stuck in the drill guide.However, without return of the device for physical evaluation, the cause remains undetermined.No change in harm was identified.

• Brand Name: DYNANITE NITI STAPLE W/INSTRS 9WX7L
• Type of Device: 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: 15484281
• MDR Text Key: 300583652
• Report Number: 1220246-2022-05542
• Device Sequence Number: 1
• Product Code: JDR
• UDI-Device Identifier: 00888867287846
• UDI-Public: 00888867287846
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K203180
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: DYNANITE NITI STAPLE W/INSTRS 9WX7L
• Device Catalogue Number: AR-8717DS-0907
• Device Lot Number: 1256115608
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/07/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other