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

Model Number	SUPERMX COMPRESSION STAPLE, 18W X 18L
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that two staples broke 6 weeks postoperatively after a tn arthrodese whilst decompression with a heel shoe.No further information received.
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.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint is confirmed.The most likely cause for the reported failure is a patient specific event.Upon visual evaluation of x-ray attached to the complaint of an alleged dynanite® supermx nitinol staple, 18w x 18l.It was concluded that the implanted dynanite supermx nitinol staple, 18w x 18l broke in several pieces.The method of bone preparation employed during the procedure, as well as the bone quality encountered, was not provided.Per dfu-0157-10.Revision 0.E.Warnings.5.Postoperatively and until healing is complete, fixation provided by this device should be considered as temporary and may not withstand weight bearing or other unsupported stress.The fixation provided by this device should be protected.The postoperative regimen prescribed by the physician should be strictly followed to avoid adverse stresses applied to the device.11.Detailed instructions on the use and limitations of this device should be given to the patient.12.Dynanite staple only: the implants are not designed to replace normal healthy bone or withstand the stress placed upon the device by full or partial weight-bearing or load bearing in the presence of nonunion, delayed union or incomplete healing.Immobilization of the treatment site using routine methods (casting, splinting, etc.) should be maintained until bone healing has occurred (4-6 weeks).

• 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: emily shafer ; 8009337001
• MDR Report Key: 18246874
• Report Number: 1220246-2023-09046
• Device Sequence Number: 6685559
• 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): 11/21/2024

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 Model Number: SUPERMX COMPRESSION STAPLE, 18W X 18L
• Device Catalogue Number: AR-8719MX-1818
• Device Lot Number: 2339127317
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/03/2023
• Supplement Date Received by Manufacturer: 01/04/2024
• Initial Report FDA Received Date: 12/01/2023
• Supplement Report FDA Received Date: 11/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown