MAUDE Adverse Event Report: BIOMET MICROFIXATION BIOMET MICROFIXATION FACIAL PLATING SYSTEM; 90 DEGREE CONTRA ANGLE SCREWDRIVER

Model Number N/A

Device Problem Device Inoperable (1663)

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

Event Date 02/17/2017

Event Type  malfunction  

Manufacturer Narrative

Review of device history records show the lot released with no recorded anomaly or deviation.Current information is insufficient to permit a valid conclusion about the cause of this event; a follow-up report will be sent upon completion of the device evaluation.Report two of two for the same event, reference report 0001032347-2017-00200.

Event Description

It was reported the internal gear in two drivers broke during a rib fracture case.A back up driver was used to complete the surgery; there was no delay or injury to the patient.

Manufacturer Narrative

Driver lot # 801390 had a very rough rotation when operated indicating excess friction between the meshing gears.The driver head was removed to inspect the gears and there was a large amount of foreign material on the drive shaft gear face that was causing the gears not to mesh correctly.The driver was functionally tested and confirmed to not transmit any torque to the blade.Further inspection revealed the main gear on the drive shaft had sheared the dowel pin that locked it in place and it was able to spin freely on the drive shaft.The most likely cause of this is excessive torque.There are no signs of manufacturing defects.Supplemental report two of two for the same event, reference report 0001032347-2017-00200-1.

Manufacturer Narrative

This report was submitted to correct the device product code and 510(k) number.The following sections were corrected: device product code: jey, corrected to hrs; g5 pma/510(k) number: k121589, corrected to k142823.Multiple mdr reports were filed for this event, please see associated report: 0001032347-2017-00200-2.

Event Description

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

• Brand Name: BIOMET MICROFIXATION FACIAL PLATING SYSTEM
• Type of Device: 90 DEGREE CONTRA ANGLE SCREWDRIVER
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer (Section G): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer Contact: michelle cole ; 1520 tradeport drive; jacksonville, FL 32218 ; 9047414400
• MDR Report Key: 6417747
• MDR Text Key: 70419107
• Report Number: 0001032347-2017-00210
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142823
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 24-1189
• Device Lot Number: 801390
• Other Device ID Number: (01)00841036123130(10)801390
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/27/2017
• Initial Date FDA Received: 03/20/2017
• Supplement Dates Manufacturer Received: Not provided; 11/29/2018
• Supplement Dates FDA Received: 05/17/2017; 12/11/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/10/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: N/A
• Patient Sequence Number: 1