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

Model Number N/A

Device Problem Premature Separation (4045)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/17/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Medical product: biomet microfixation 1.5mm system high torque x-lock standard blade catalog #: 15-1196 lot #: ni.Therapy date: (b)(6) 2018.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.Multiple mdr reports were filed for this event, please see associated report: 0001032347-2018-00689.

Event Description

It was reported during a complex frontal case a long blade that goes with the manual driver handle was not retaining the screw during a surgery.The surgeon was still able to insert the screws, he had to hold the screw to the driver tip with his finger the best he could.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

Reported event was unable to be confirmed due to limited information received from the customer.The product identity could not be confirmed due to the part not being returned.The 1.5mm system high torque x-lock standard blade (part# 15-1196, lot# unknown) and thinflap system cross-drive, self-drilling screw, 1.5x4mm (part# 91-6704, lot# unknown) were not returned and therefore could not be visually evaluated or functionally tested.Because the blade could not be functionally tested for retention with a screw, the complaint cannot be verified.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.There are no indications of manufacturing defects.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.Multiple mdr reports were filed for this event, please see associated report: 0001032347-2018-00689-2.

• Brand Name: THINFLAP SYSTEM CROSS-DRIVE, SELF-DRILLING SCREW, 1.5X4MM
• Type of Device: BONE SCREW
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 8056490
• MDR Text Key: 126995911
• Report Number: 0001032347-2018-00749
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2018
• 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?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1