MAUDE Adverse Event Report: BIOMET MICROFIXATION TRAUMAONE SYSTEM OMNIMAX SELF DRILLING X-DRIVE SCREW 2.0X11MM; BONE SCREW

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/11/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical product: biomet microfixation omnimax arch bar, catalog #: 01-0298, lot #: ni.Therapy date: (b)(6) 2018.Customer has indicated that the product will not be returned to zimmer biomet for investigation, the devices were discarded by the facility.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported this was the first time the surgeon used the omnimax system.The surgeon was attempting to insert an 11 mm screw into the posterior mandible over a tooth root; the screw was inserted at an angle.The screw fractured just below the head and the shaft of the screw was removed after additional drilling.As a result of this issue, the surgeon decided to remove the omnimax devices and used arch bars instead.There was a delay of 20-25 minutes due to the removal of the devices.No additional patient consequences were reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The complaint is that a screw fractured below the head during an omnimax case, causing a 20-25 minute delay to remove the system.It was reported that the part was removed because of the fracture, therefore the complaint is considered confirmed.Since the product was not returned, visual and functional testing cannot be performed.The distributor reported that the "surgeon was attempting to insert an 11mm screw into the posterior mandible over a tooth root." additionally, it was indicated the screw was inserted angle.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 the surgeon not following the instructions for use (ifu) for this product.The ifu for this product informs of precautions to be taken with this product in the section titled precautions: sharp angles and small bending radii must be avoided to reduce the risk of the device breaking.Placement sites of screws should be chosen to avoid tooth roots and compression of the tissue by the arch bar.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: TRAUMAONE SYSTEM OMNIMAX SELF DRILLING X-DRIVE SCREW 2.0X11MM
• Type of Device: BONE 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: 7260263
• MDR Text Key: 99605276
• Report Number: 0001032347-2018-00081
• 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: 03/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2018
• 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: 91-5711
• 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: 02/27/2018
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention