MAUDE Adverse Event Report: BIOMET MICROFIXATION 9; 90 DEGRE 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

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.When the drivers were received it was identified they were from different lots.This is report two of two for the same event; reference report 0001032347-2017-00496.

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

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.The driver was functionally tested using a blade to insert a screw into a pre-drilled hole in a white oak block.The driver was successfully able to fully seat the screw then remove the screw.The complaint was unconfirmed as there was no issue found with the driver.The most likely cause of the complaint could not be determined because the product functioned as intended.There are no indications of manufacturing defects.This is supplemental report two of two for the same event; supplemental report two of two is reported on mfr # 0001032347-2017-00496-2.

• Brand Name: 9
• Type of Device: 90 DEGRE 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: 6669174
• MDR Text Key: 78482324
• Report Number: 0001032347-2017-00520
• 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
• Report Date: 06/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2017
• 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: 618770
• Other Device ID Number: (01)00841036123130(10)618770
• 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: 08/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/08/2015
• 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