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 Type  malfunction  

Manufacturer Narrative

Without a product return, no product evaluation is able to be conducted.The lot number is unknown; therefore the device history records are unable to be reviewed.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.

Event Description

It was reported two drivers did not perform well during surgery.Additional information was requested but has not been received at this time.

Manufacturer Narrative

Review of device history records show the lot released with no recorded anomaly or deviation.The device evaluation is in progress, a follow up report will be sent upon completion of the device evaluation.When the drivers were received it was identified they were from different lots.This is report one of two for the same event; reference report: 0001032347-2017-00520.Updated based on the receipt of the device for evaluation.

Manufacturer Narrative

The screwdriver was returned without packaging.The product was visually evaluated and it was found to be in good overall condition.There were scratches and normal signs of wear on the instrument; no significant discoloration was observed.There is some friction when rotating the knob.The complaint was confirmed as there is friction while rotating the knob on the driver and the blade does not rotate when the knob is turned.Applying excessive torque after the screw has been seated onto the plate may cause a fracture in the internal gearing of the driver.The most likely cause of the complaint is determined to be due to excessive torque applied to the driver.In the warnings and precautions section of the instructions for use, it is stated, ¿avoid undue stress or strain when handling or cleaning instruments.¿ there are no indications of manufacturing defects.This is supplemental report one of two for the same event; supplemental report two of two is reported on mfr # 0001032347-2017-00520-1.

• 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: 6637323
• MDR Text Key: 77527997
• Report Number: 0001032347-2017-00496
• Device Sequence Number: 1
• Product Code: JEY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK121589
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2017
• 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: 488010
• Other Device ID Number: (01)00841036123130(10)488010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/16/2016
• 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