MAUDE Adverse Event Report: BIOMET MICROFIXATION BIOMET MICROFIXATION STERNALOCK BLU STERNAL CLOSURE SYSTEM; 2.4X14MM CANCELOUS LOCKING SCREW

Model Number N/A

Device Problem Failure to Advance (2524)

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

Event Date 04/28/2017

Event Type  malfunction  

Manufacturer Narrative

It is reported the screw was discarded by the facility, therefore no product evaluation is able to be conducted.The lot number 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.

Event Description

A billing sheet was submitted indicating one screw was wasted.Upon follow up it was reported the screw was inserted and did not seem to seat well, therefore the screw was removed.A new screw of the same size was used to complete the procedure.The new screw seated well into the plate and locked in.

• Brand Name: BIOMET MICROFIXATION STERNALOCK BLU STERNAL CLOSURE SYSTEM
• Type of Device: 2.4X14MM CANCELOUS LOCKING 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 cole ; 1520 tradeport drive; jacksonville, FL 32218 ; 9047414400
• MDR Report Key: 6743337
• MDR Text Key: 81002368
• Report Number: 0001032347-2017-00593
• 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: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2017
• 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: 73-2414
• 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: 06/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 59 YR