MAUDE Adverse Event Report: CAYENNE MEDICAL APERFIX; CORING REAMER

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 01/21/2011

Event Type  malfunction  

Manufacturer Narrative

This report is being submitted late, due to an internal retrospective review.A follow up mdr will be submitted to provide the recall number.

Event Description

It was reported to cayenne medical that " the reamer used in a procedure backed out, and the teeth on the reamer flowered over.".

• Brand Name: APERFIX
• Type of Device: CORING REAMER
• Manufacturer (Section G): CAYENNE MEDICAL; 16597 n 92nd street; scottsdale AZ 85260
• Manufacturer Contact: shima hashemian ; 16597 n 92nd street; scottsdale, AZ 85260 ; 4804582196
• MDR Report Key: 7097734
• MDR Text Key: 94411918
• Report Number: 3006108336-2017-00014
• Device Sequence Number: 1
• Product Code: HTO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 12/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/08/2011
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: TBD
• Patient Sequence Number: 1