MAUDE Adverse Event Report: BIOMET MICROFIXATION OMNIMAX SELF DRILLING X-DRIVE SCREW 2.0X9MM; SCREW, FIXATION, INTRAOSSEOUS

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/27/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported during a mandibular fracture repair procedure an omnimax 9mm screw snapped in half while inserting into the patient's left maxilla.The surgeon slightly opened the maxilla to retrieve the broken screw.The delay was five minutes while they worked to remove the broken fragment from the patient.The surgery was completed using a 7mm screw.The upper half of the screw will be returned; the bottom half was lost in the trash after being removed from the patient.No additional patient consequences were reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.The screw was visually evaluated and found to be fractured.The slots in the head of the screws show signs of damage where the blade dug into the side walls, indicating the screw retained the blade allowing a high torque on the screw to be achieved.The screw has been fractured at the first minor diameter near the head and perpendicular to the length of the screw.The fracture is typical of an over torqued screw.There is no sign of discoloration.There are no indications of manufacturing defects.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Investigation results concluded that the reported event was due to excessive force while attempting to insert the screw.The instructions for use (ifu) for this product states in the section titled warnings: 3.Intraoperative fracture of screws can occur if excessive force (torque) is applied while seating bone screws.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: OMNIMAX SELF DRILLING X-DRIVE SCREW 2.0X9MM
• Type of Device: SCREW, FIXATION, INTRAOSSEOUS
• 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: 7189187
• MDR Text Key: 97292411
• Report Number: 0001032347-2018-00030
• Device Sequence Number: 1
• Product Code: DZL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK143336
• 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,Followup
• Report Date: 06/21/2018

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?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 91-5709
• Device Lot Number: UNKNOWN
• Other Device ID Number: (01)00841036181055
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/27/2017
• Initial Date FDA Received: 01/15/2018
• Supplement Dates Manufacturer Received: 05/24/2018
• Supplement Dates FDA Received: 06/21/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 39 YR