MAUDE Adverse Event Report: BIOMET MICROFIXATION BIOMET MICROFIXATION STERNALOCK BLU STERNAL CLOSURE SYSTEM; STERNALOCK SCREW

Model Number N/A

Device Problem Device Or Device Fragments Location Unknown (2590)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/09/2014

Event Type  malfunction  

Event Description

The sales associate reported the surgeon saw a screw floating on one of his patient scans.The surgeon determined that the floating screw is not a clinical concern at this time.

Manufacturer Narrative

The package insert for this product states migration, bending, fracture or loosening of the implant are possible adverse effects.Without a product return, no product evaluation is able to be conducted.The part and lot history of the implanted unit is unknown; therefore, the device history records are unable to be reviewed.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.

• Brand Name: BIOMET MICROFIXATION STERNALOCK BLU STERNAL CLOSURE SYSTEM
• Type of Device: STERNALOCK SCREW
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer (Section G): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer Contact: michelle coldwater ; 1520 tradeport drive; jacksonville, FL 32218 ; 9047414400
• MDR Report Key: 4143253
• MDR Text Key: 16782102
• Report Number: 0001032347-2014-00341
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK110574
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/09/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1