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 Type  Injury  

Manufacturer Narrative

This report is being submitted late, due to an internal retrospective review.

Event Description

It was reported to cayenne medical that " the guidewire offered with the reamer broke at the tip, then tried to ream, and it took about an hour to pull out the entire piece with a rasp.".

• Brand Name: APERFIX
• Type of Device: CORING REAMER
• Manufacturer (Section G): CAYENNE MEDICAL; 16597 n 92nd st; scottsdale AZ 85260
• Manufacturer Contact: shima hashemian ; 16597 n 92nd st; scottsdale, AZ 85260 ; 4804582196
• MDR Report Key: 7104873
• MDR Text Key: 94473110
• Report Number: 3006108336-2017-00013
• 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
• Type of Report: Initial
• Report Date: 12/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention