MAUDE Adverse Event Report: BIOMET MICROFIXATION PLATE 12-HOLE WIDE LADDER; BONE PLATE

Model Number N/A

Device Problems Bent (1059); Fracture (1260); Migration or Expulsion of Device (1395)

Patient Problem Unspecified Infection (1930)

Event Date 05/13/2016

Event Type  Injury  

Manufacturer Narrative

The warnings in the package insert state this type of event can occur.The product was not returned by the hospital.Because the lot number is unknown, the device history records could not be pulled and 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.This is report 2 of 2 for the same event.Report 1 of 2 is reported on mfr #0001032347-2016-00281.

Event Description

It was reported that sometime in (b)(6) (within a year of implantation) a sternalock blu (sl blu) revision took place due to infection in the xiphoid area.The hospital is culturing the trays to be sure that they are sterile.While the surgeon was removing the hardware, he noticed that the top 2 screws used in the manubrium were broken.1 screw that was used with a wide ladder plate had backed out and was broken as well.It is reported a total of 4 broken screws and 1 bent screw.The surgeon used a power driver to remove the remaining screws and the patient did not retain any hardware.The patient was not replated.

• Brand Name: PLATE 12-HOLE WIDE LADDER
• Type of Device: BONE PLATE
• 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: 5697948
• MDR Text Key: 46512974
• Report Number: 0001032347-2016-00282
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK011076
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 05/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 73-2634
• 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: 05/13/2016
• 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: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention