MAUDE Adverse Event Report: BIOMET MICROFIXATION THINFLAP SYSTEM CROSS-DRIVE, SELF-DRILLING SCREW 1.5X4MM; PLATE, BONE

Model Number N/A

Device Problem Material Deformation (2976)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/07/2020

Event Type  malfunction  

Manufacturer Narrative

Zimmer biomet complaint (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.Distributor reporting on behalf of the hospital.The user facility is foreign; therefore, a facility medwatch report will not be available.Report source - (b)(6).

Event Description

It was reported the screw would not enter the patient's skull bone.No adverse events were reported as a result of the malfunction.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The complaint is confirmed.The qty one 1.5x4mm x-drive tf sd screw ea (part# 91-6704, lot# unk) was returned for investigation.A visual inspection was conducted.The screw tip shows signs of wear.Functional testing was completed by attempting to insert the screws into a piece of white oak wood using a 01-7390 driver handle lot 048760 with a 15-1196 1.5mm bit lot number 406650.When an attempt was made to turn the screw into the wood the screw tip was unable to penetrate the wood surface.The dhr will not be reviewed as the lot number remains unknown.There are no indications of manufacturing defects.For this part (91-6704) and the previous one year (from the notification date) regarding the lack of insertion of screw, there is a complaint rate of (b)(4) which is no greater than the occurrence listed in the application fmea.The most likely underlying cause of the complaint is excessive force applied during an insertion attempt, beyond what the implant is designed to encounter.It is possible that the tip wear occurred due to over torqueing, an off axis insertion attempt, or attempting to insert the screw into a patient with high bone density.If any further information is found which would change or alter any conclusions or information, a supplemental report 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 1.5X4MM
• Type of Device: PLATE, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 10020557
• MDR Text Key: 191251727
• Report Number: 0001032347-2020-00226
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 00841036134808
• UDI-Public: 00841036134808
• 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,user faci
• Type of Report: Initial,Followup
• Report Date: 07/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2020
• 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
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1