MAUDE Adverse Event Report: BIOMET MICROFIXATION BIOMET MICROFIXATION THORACIC FIXATION SYSTEM; 90 DEG CONTRA ANGLE SCREWDRIVER

Model Number N/A

Device Problem Device Inoperable (1663)

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

Event Date 09/16/2016

Event Type  malfunction  

Manufacturer Narrative

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 0001032347-2016-00597.

Event Description

The sales associate reported two right angle drivers in which the gears were slipping causing the blade not to spin, or the mechanism for releasing the blade/fixation pin would not release leaving the driver attached to the fixation pin.Additional instruments were used to complete the surgery.No surgical delay or adverse events were reported.

Manufacturer Narrative

The product was returned for evaluation.The product identity was confirmed in the evaluation.The device history records were reviewed in the evaluation and no non-conformances were found.The driver was visually inspected and show signs of normal use.The driver was functionally tested and was found not to function as intended because when load was applied to the knob, it would spin freely without turning the blade or inserting the screw.The driver did pass the max gage inspection.The complaint is confirmed as the driver did not function as intended.The most-likely cause was determined to be excessive torque applied to the driver.This is report two of two for the same event.Report one of two is reported on mfr #0001032347-2016-00597.

Manufacturer Narrative

This is supplemental report two of two for the same event, reference 0001032347-2016-00597-2.

• Brand Name: BIOMET MICROFIXATION THORACIC FIXATION SYSTEM
• Type of Device: 90 DEG 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: 6036197
• MDR Text Key: 57697135
• Report Number: 0001032347-2016-00598
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK142823
• 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: 09/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2016
• 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: 417430
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/08/2015
• 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