MAUDE Adverse Event Report: BIOMET MICROFIXATION THINFLAP SYSTEM CROSS-DRIVE, SELF-DRILLING SCREW 1.X4MM; BONE SCREW

Model Number N/A

Device Problem Difficult to Insert (1316)

Patient Problem Blood Loss (2597)

Event Date 02/22/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).(b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported a screw complication led to bleeding in a cranial procedure.The screw slipped on the cranial bone when the surgeon attempted to insert it during a surgery.As a result, the patient¿s vein inside of the cranial bone was damaged and bled 500 cc.The surgeon stated that the screw did not go ahead inside of the cranial bone well at the time.The surgery was completed using other company¿s products.The surgery delay was over 30 minutes.No additional patient consequences were reported.

Event Description

In regards to requests for additional information, the distributor responded the screw, not another device, caused the damage to the vein.The screw did not disengage from the blade, it was slipping on the bone face.There was a delay greater than thirty minutes due the bleeding, however the exact duration was not provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Distributor reported that the product was discarded.No product was returned and no functional tests or inspections could be performed.No pictures were provided.For these reasons, the complaint could not be verified and the most likely underlying cause of the complaint could not be determined.Potential contributing factors could be the density of the patients bone and the insertion angle of the screw.The instructions for use (ifu) for this product has the following information regarding bone screws: bone screws.The screwdriver, which has been designed, for a particular system of screws must always be used to be sure that proper screwdriver/screw head connection is achieved.Incorrect alignment or fit of the screwdriver to the screw head may increase the risk of damage to the implant or screwdriver.Excessive torque can cause the screw to fracture.Self drilling screws may fracture, bend or break if used in a bicortical application.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.A summary of the investigation has been sent to the complainant.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: THINFLAP SYSTEM CROSS-DRIVE, SELF-DRILLING SCREW 1.X4MM
• Type of Device: BONE SCREW
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 7438041
• MDR Text Key: 105726443
• Report Number: 0001032347-2018-00204
• Device Sequence Number: 1
• Product Code: JEY
• Combination Product (y/n): N
• PMA/PMN Number: PK121589
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup,Followup
• Report Date: 09/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2018
• 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: 91-6704
• Device Lot Number: UNKNOWN
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention