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

Model Number	SUPERMX COMPRESSION STAPLE, 18W X 18L
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/27/2022
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional Manufacturer Narrative
This supplemental submission is to add a part number.

• Brand Name: SUPERMX COMPRESSION STAPLE, 18W X 18L
• 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: 15931169
• Report Number: 1220246-2022-05901
• Device Sequence Number: 6544203
• Product Code: JDR
• UDI-Device Identifier: 00888867300941
• UDI-Public: 00888867300941
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Followup
• Report Date (Section B): 12/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: SUPERMX COMPRESSION STAPLE, 18W X 18L
• Device Catalogue Number: AR-8719MX-1818
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2022
• Supplement Date Received by Manufacturer: 09/27/2022
• Initial Report FDA Received Date: 12/07/2022
• Supplement Report FDA Received Date: 12/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown