MAUDE Adverse Event Report: ARTHREX, INC. SUPERMX COMPRESSION STAPLE, 18W X 18L; STAPLE, FIXATION, BONE

Model Number SUPERMX COMPRESSION STAPLE, 18W X 18L

Device Problem Fracture (1260)

Patient Problem Failure of Implant (1924)

Event Date 09/27/2022

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

It was reported that a dynanite mx device broke inside the patient after the implantation.The device was implanted 6 months ago and then had to be explanted during a revision surgery due to the fracture of the compression clamp.No further information received.

Manufacturer Narrative

This supplemental submission is to add a part number.

• Brand Name: SUPERMX COMPRESSION STAPLE, 18W X 18L
• 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: 15931169
• MDR Text Key: 304960121
• Report Number: 1220246-2022-05901
• Device Sequence Number: 1
• Product Code: JDR
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K203180
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 12/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SUPERMX COMPRESSION STAPLE, 18W X 18L
• Device Catalogue Number: AR-8719MX-1818
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other