MAUDE Adverse Event Report: BIOMET MICROFIXATION RIBFIX BLU SYSTEM TEMPORARY FIXATION SCREW, CONTRA ANGLE

Model Number N/A

Device Problem Separation Failure (2547)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/27/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Medical device: biomet microfixation 90° contra angle driver catalog #: 24-1189, 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 reports: 0001032347-2018-00719.

Event Description

It was reported the pins were difficult to load and remove from the driver.One of the contra angle drivers was having difficulty retaining temporary pins and blades when the scrub tech and surgeon would try loading them into the driver.Once loaded the pins/blades became extremely difficult to remove from the driver.The surgeon decided to set the driver in question aside and not use it the remainder of the procedure.This caused a slight delay in the case when fiddling with the blades, but no harm to the patient.After the procedure was over the sales representative attempted to test the driver with a temporary pin to see if she could get the driver to retain it and the pin became irreversibly lodged in the driver.No adverse events have been reported as a result of the malfunction.

Manufacturer Narrative

Complaint sample was evaluated and the reported event was confirmed.The product identities were confirmed.The 90° contra angle driver (part# 24-1189, lot# 129290) was returned with a ribfix blu system temporary fixation screw, contra angle (part# 76-0017, lot# 246900) inside the collet.The driver was functionally tested by attempting to remove the screw.The screw could not be removed, therefore the complaint is confirmed.The driver was disassembled for further inspection.When the cover of the head assembly was removed, it was noted that the screw had rotated slightly inside the driver, which prevented it from being removed.The screw was rotated and removed from the collet.There was some debris that fell out upon removal of the screw and a brownish-red residue was observed on the shaft of the screw as well as on the collet of the driver.The temporary screw was reinserted into the collet and found to be sticky during reinsertion.The screw did have difficulty retaining inside the driver.The end of the screw that gets locked into the driver was also found to have debris inside the locking groove.After cleaning the screw's interface area, it was able to be retained in the driver.Based on the debris and residue, it was likely that the driver and screw were autoclaved while assembled.Investigation results concluded that the screw being stuck in the driver is due to excessive torque being applied beyond what is required to seat the screw.The excessive torque wore down the screw and collet, then caused the collet to rotate around the screw.The instructions for use (ifu) for these products states in the section titled "warnings and precautions": avoid undue stress or strain when handling or cleaning instruments.It also states in the section titled "cleaning instructions using an automatic washer/disinfector and detergent": disassemble reusable instruments.The device history records (dhr) for these products were reviewed and no discrepancies were found.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.The following fields were updated: multiple mdr reports were filed for this event, please see associated reports: 0001032347-2018-00719-3.

Event Description

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

• Brand Name: RIBFIX BLU SYSTEM TEMPORARY FIXATION SCREW, CONTRA ANGLE
• Type of Device: TEMPORARY FIXATION SCREW
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 8011026
• MDR Text Key: 125793944
• Report Number: 0001032347-2018-00720
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• PMA/PMN Number: K142823
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 02/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2018
• 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: 76-0017
• Device Lot Number: 246900
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1