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

Model Number SUPERMX NITI STAPLE W/ INSTRS, 18W X 18L

Device Problems Patient-Device Incompatibility (2682); Patient Device Interaction Problem (4001)

Patient Problem Fever (1858)

Event Date 12/05/2019

Event Type  Injury  

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.

Event Description

It was reported after foot reconstruction procedure arthrocell was used.The patient had an adverse reaction including fever spikes one day post-op.There were also four screws and two staples implanted.No revision is planned at this time.Currently the doctor is researching the source of the reaction.

• Brand Name: SUPERMX NITI STAPLE W/ INSTRS, 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: 9506161
• MDR Text Key: 187932336
• Report Number: 1220246-2019-01517
• Device Sequence Number: 1
• Product Code: JDR
• UDI-Device Identifier: 00888867300880
• UDI-Public: 00888867300880
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172052
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SUPERMX NITI STAPLE W/ INSTRS, 18W X 18L
• Device Catalogue Number: AR-8719MXDS-1818
• Device Lot Number: 912993392
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/06/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/01/2019
• 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