MAUDE Adverse Event Report: BIOMET MICROFIXATION 1.5MM SYSTEM HIGH TORQUE(HT),SD,X-DR,SCR,5/PK 1.5MM X 6MM TITANIUM; PLATE, BONE

Model Number N/A

Device Problem Fracture (1260)

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

Event Date 05/18/2020

Event Type  malfunction  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Occupation: distributor.The user facility is foreign; therefore, a facility medwatch report will not be available.Report source - (b)(6).

Event Description

It was reported that nine (9) screws fractured upon implantation.The screw heads were reported to have sheared off.No adverse events have been reported as a result of the malfunction.

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The complaint is confirmed.The nine (9) 1.5x6mm ht sd x-dr scr 5-pk (item# 95-6106, lot# unk) were not returned for investigation as it was reported that they were discarded.For this reason, no functional testing or visual inspections could be conducted.A video was sent with the complaint, which demonstrates the reported failure.In the video, the user inserts the screw into a block of wood.The screw is nearly fully inserted and the screw shaft fractures near the head of the screw just before fully seating.The dhrs for these screws could not be reviewed due to the lot number remaining unknown.There are no indications of manufacturing defects.For this part (95-6106) in the previous five years (from the notification date), there is a complaint rate of 0.29%, which is no greater than the occurrence listed in the application fmea.The most likely underlying cause of the complaint could not be determined from the available information.Screw shaft fractures are typically caused by over torquing, off-axis torque, off-axis insertion attempts, or attempting to insert the screw into hard or high density bone.The insertion technique demonstrated by the user in the attached video did not indicate any of these possible causes contributed to the reported failures.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.

• Brand Name: 1.5MM SYSTEM HIGH TORQUE(HT),SD,X-DR,SCR,5/PK 1.5MM X 6MM TITANIUM
• Type of Device: PLATE, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 10209389
• MDR Text Key: 197081794
• Report Number: 0001032347-2020-00283
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 00841036056674
• UDI-Public: 00841036056674
• Combination Product (y/n): N
• PMA/PMN Number: K121589
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 12/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2020
• 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: 95-6106
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1