MAUDE Adverse Event Report: MICROAIRE SURGICAL INSTRUMENTS MICROAIRE ENDOTINE; FIXATION DEVICE

Model Number CFD-22102

Device Problems Component Missing (2306); Device Packaging Compromised (2916); Packaging Problem (3007)

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

Event Date 09/09/2015

Event Type  malfunction  

Manufacturer Narrative

Due to indication of only one device in box, which caused a slight delay in surgery, it was determined that this event is reportable.

Event Description

The customer reported that there was only one implant in the box.The product is packaged as a two (2) pack.The shortage resulted in a slight delay in surgery.

• Brand Name: MICROAIRE ENDOTINE
• Type of Device: FIXATION DEVICE
• Manufacturer (Section D): MICROAIRE SURGICAL INSTRUMENTS; 3590 grand forks boulevard; charlottesville VA 22911
• Manufacturer (Section G): MICROAIRE SURGICAL INSTRUMENTS; 3590 grand forks boulevard; charlottesville VA 22911
• Manufacturer Contact: donna elliott ; 3590 grand forks boulevard; charlottesville, VA 22911 ; 4349758370
• MDR Report Key: 5127340
• MDR Text Key: 27809840
• Report Number: 2020601-2015-00080
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K032770
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Report Date: 09/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 11/30/2017
• Device Model Number: CFD-22102
• Device Catalogue Number: CFD-22102
• Device Lot Number: 260409
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/05/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/08/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other