MAUDE Adverse Event Report: CAYENNE MEDICAL APERFIX; REAMER

Model Number CM-7110

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Tissue Damage (2104)

Event Type  Injury  

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 (b)(6) medical that "during an acl revision for aperfix, the tibial portion came out fine.The titanium pin of the aperfix femoral implant was removed with no issue.Ten (10) mm guide pin with stopper was placed and the 10mm coring reamer was run over the top.While reaming, it was observed that a lot of force was being used, and therefore; the reaming was stopped to check progress.When stopped, the first 15mm of the reamer was peeled back causing a little damage to the medial portion of the lateral condyle.The reamer was removed and no metal was left behind.".

• Brand Name: APERFIX
• Type of Device: REAMER
• Manufacturer (Section D): CAYENNE MEDICAL; 16597 n 92nd street; scottsdale AZ 85260
• 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: 7088801
• MDR Text Key: 94069915
• Report Number: 3006108336-2017-00012
• 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: 12/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CM-7110
• Device Catalogue Number: CM-7110
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2011
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/10/2011
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: TBD
• Patient Sequence Number: 1
• Patient Outcome(s): Other