MAUDE Adverse Event Report: CAYENNE MEDICAL APERFIX

Model Number N/A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Manufacturer Narrative

No information regarding the device location.The lot number was not provided for the device, and dhr and complaint history could not be reviewed.A follow up report will be submitted if any additional information is received.Cayenne will continue to monitor for future events.

Event Description

During literature review of the aperfix device "comparison of different methods of femoral fixation anterior cruciate ligament reconstruction " , it was noted that post operation, an aperfix device has failed.No further information was noted regarding this event.

• Brand Name: APERFIX
• Type of Device: APERFIX
• Manufacturer (Section D): CAYENNE MEDICAL; 16597 n 92nd street; 101; scottsdale AZ 85260
• Manufacturer (Section G): CAYENNE MEDICAL; 16597 n 92nd street; 101; scottsdale AZ 85260
• Manufacturer Contact: shima hashemian ; 16597 n 92nd street; 101; scottsdale, AZ 85260 ; 4805023661
• MDR Report Key: 9965315
• MDR Text Key: 187997731
• Report Number: 3006108336-2020-00009
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083612
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: APERFIX
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/16/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention