MAUDE Adverse Event Report: BIOMET MICROFIXATION THINFLAP SYSTEM CROSS-DRIVE, SELF-DRILLING SCREW 1.5 X 4 MM; SCREW, BONE

Model Number N/A

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/23/2018

Event Type  malfunction  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).Unique identifier (udi) number: (b)(4).(b)(4).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 the screw was unable to be gripped by the blade during a procedure.Attempts have been made and no further information has been provided.No adverse events have been reported as a result of the malfunction.

Manufacturer Narrative

Complaint sample was evaluated and the reported event was confirmed.Product identity is confirmed.The screw was returned without original packaging for evaluation.On visual inspection, the tip of the screw shows minimal damage.However, the drive on the screw head shows significant damage and stripping, indicating an insertion attempt.Functional testing for the screw's retention was attempted by mating it to 15-1196 1.5mm ht x-lock blade with a 01-7390 green handle screwdriver assembly; the screw would not retain to the blade and repeatedly fell off.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 damage during the insertion attempt by way of an off-axis insertion attempt, over torqueing, using the incorrect blade, or the patient having high bone density.The unknown blade was not returned, therefore functional testing and inspections could not be made regarding this part and how it relates to the complaint and potential root causes.The instruction for use (ifu) for this product has the following information regarding bone screws: 1.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.2.Incorrect alignment or fit of the screwdriver to the screw head may increase the risk of damage to the implant or screwdriver.3.Excessive torque can cause the screw to fracture.4.Self drilling screws may fracture, bend or break if used in a bicortical application.There are no indications of manufacturing defects.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.

Event Description

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

• Brand Name: THINFLAP SYSTEM CROSS-DRIVE, SELF-DRILLING SCREW 1.5 X 4 MM
• Type of Device: SCREW, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 8129814
• MDR Text Key: 129233260
• Report Number: 0001032347-2018-00836
• Device Sequence Number: 1
• Product Code: JEY
• Combination Product (y/n): N
• PMA/PMN Number: K121589
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 02/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 91-6704
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/05/2018
• Initial Date FDA Received: 12/04/2018
• Supplement Dates Manufacturer Received: 01/09/2019
• Supplement Dates FDA Received: 02/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN BLADE CATALOG #: NI LOT #: NI; UNKNOWN BLADE CATALOG #: NI LOT #: NI