MAUDE Adverse Event Report: ARTHREX, INC. DYNANITE NITI STAPLE W/INSTRS 18WX18/15L; STAPLE, FIXATION, BONE

Model Number DYNANITE NITI STAPLE W/INSTRS 18WX18/15L

Device Problems Break (1069); Appropriate Term/Code Not Available (3191)

Patient Problem Insufficient Information (4580)

Event Date 05/02/2022

Event Type  malfunction  

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.

Event Description

On (b)(6) 2022, it was reported by a sales representative via phone that an ar-8771-0422x dynamite compression plate was implanted on patient during a tarsal metatarsal fusion procedure on (b)(6) 2021.On (b)(6) 2022, it was noticed to be broken via x-ray.Patient underwent tarsal metatarsal fusion revision surgery on (b)(6) 2022 and had the ar-8771-0422x dynamite compression plate along with the staples from an ar-8719ds-181815 dynamite nitinol staple implant system removed.Surgeon completed the revision surgery by implanting devices from another manufacturer.Case was completed successfully and no further issues has been reported.

Manufacturer Narrative

Complaint not confirmed.Upon visual inspection, it was noted that there was damage/tool marks to the top of the staple.No other problems were noted with the device.The cause remains undetermined however, a likely cause is contributed to the removal process of the staple.

• Brand Name: DYNANITE NITI STAPLE W/INSTRS 18WX18/15L
• 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: 14469444
• MDR Text Key: 292470692
• Report Number: 1220246-2022-04949
• Device Sequence Number: 1
• Product Code: JDR
• UDI-Device Identifier: 00888867288188
• UDI-Public: 00888867288188
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K203180
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 07/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2022
• 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 18WX18/15L
• Device Catalogue Number: AR-8719DS-181815
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other