MAUDE Adverse Event Report: BIOMET MICROFIXATION STERNALOCK BLU BIOMET MICROFIXATION STERNAL CLOSURE SYSTEM; PLATE; 6 HOLE HEX PLATE

Model Number N/A

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Injury (2348)

Event Type  Injury  

Manufacturer Narrative

It is reported the facility discarded the plates and screws, therefore no product evaluation is able to be conducted.The device history records are unable to be reviewed as the lot number is unknown, therefore manufacture date is unknown.Based on the information provided the most likely root cause is the patient was non-compliant with post operative instructions.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.The part and lot numbers of the explanted screws are unknown.Implant date and explant date are unknown.Report one of two for the same event, see also 0001032347-2015-00446.

Event Description

The sales associate reported the patient did not follow the sternal precautions post operatively; the patient lifted something which caused a tear in the costochondral cartilage between the sternum and the rib.He reported the patient did not have a sternal dehiscence and the plates did not fail.The tear resulted in the doctor performing a chest flap to repair the damage and removing the plates and screws.

• Brand Name: STERNALOCK BLU BIOMET MICROFIXATION STERNAL CLOSURE SYSTEM
• Type of Device: PLATE; 6 HOLE HEX 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: 5205412
• MDR Text Key: 30545093
• Report Number: 0001032347-2015-00445
• 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: Other
• Type of Report: Initial
• Report Date: 10/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: SP-2890
• Device Lot Number: UNKNOWN
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/08/2015
• Initial Date FDA Received: 11/05/2015
• 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; Required Intervention