MAUDE Adverse Event Report: BIOMET MICROFIXATION CONTRA ANGLE TEMPORARY FIXATION SCREW

Model Number N/A

Device Problem Separation Failure (2547)

Patient Problem No Code Available (3191)

Event Date 10/24/2017

Event Type  Injury  

Manufacturer Narrative

Without a product return, 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.This is report one of two for the same event, reference report 0001032347-2017-00818.

Event Description

It was reported during a rib fixation procedure, the blade (76-0017) became stuck in the bone as well as in the driver (24-1189).The blade would not release from the driver in the normal manner.The surgeon was able to pry the driver from the blade (with the blade still in the patient¿s bone), but was unable to re-engage the driver and blade so that the blade could be backed out of the bone.The surgeon then used forceps to pull the blade from the patient¿s bone.As a result, a new hole was made in the bone.Another driver and blade were used and the surgery was then completed successfully.There was a three minute delay.

• Brand Name: CONTRA ANGLE TEMPORARY FIXATION SCREW
• Type of Device: TEMPORARY FIXATION 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: 7048467
• MDR Text Key: 92626170
• Report Number: 0001032347-2017-00817
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK142823
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 76-0017
• 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: 10/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention