MAUDE Adverse Event Report: BIOMET MICROFIXATION STERILE TRAC SYSTEM STERILE TRAC 5 XD THINFLAP 1.5 X 4.0 MM SCREW; SCREW, FIXATION, BONE

Model Number N/A

Device Problem Difficult to Insert (1316)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/01/2018

Event Type  malfunction  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).Unique identifier (udi) #: (b)(4).Foreign country: (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 one screw could not be inserted in the patient's bone during a procedure to close the cranium.The surgery was completed with another device.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

This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.The product was returned for evaluation.On visual inspection the screw is in fair overall condition.There is some damage apparent to the cross drive of the screw head and screw threads; white foreign matter on the threads; and dulling of the tip indicating an insertion attempt was made.Functional testing was performed by attempting to drive the screw into a block of oak wood using a hand driver assembly.The screw could not be inserted; therefore the complaint is confirmed.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.The most likely underlying cause of the complaint is damage sustained during the initial insertion attempt.This could have been due to an off-axis attempt, using the wrong blade, excessive torque being applied, or the patient having high bone density.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 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.The same size screw was used to complete the procedure.There was a delay time, but under ten (10) minutes.

• Brand Name: STERILE TRAC SYSTEM STERILE TRAC 5 XD THINFLAP 1.5 X 4.0 MM SCREW
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 8179057
• MDR Text Key: 131320835
• Report Number: 0001032347-2018-00882
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• PMA/PMN Number: K972322
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 04/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2018
• 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: SP-ST5-6704
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1