MAUDE Adverse Event Report: BIOMET MICROFIXATION CONTRA-ANGLE SCREWDRIVER; SCREW DRIVER

Model Number N/A

Device Problems Sticking (1597); Device Inoperable (1663)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Because the lot number is unknown, the device history records could not be pulled and reviewed.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.

Event Description

A distributor reported a contra angle screw driver that locked up.The distributor tried to turn the bottom piece but it didn't move.There is no surgery or patient involvement for this event.

Manufacturer Narrative

The product identity was confirmed in the product evaluation.The driver was visually evaluated and looked to be in fair condition.The driver was functionally evaluated and the bottom handle was frozen and could not be turned.The complaint was confirmed for the broken driver.The most likely cause is determined to be not properly following cleaning and sterilization instructions.The chemical residues from the driver were not properly rinsed off.Also, this contra angle design precedes the current contra angle design and therefore the instrument has been in the field for a significant period of time.The instructions for use provides cleaning instructions.

• Brand Name: CONTRA-ANGLE SCREWDRIVER
• Type of Device: SCREW DRIVER
• 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: 6567331
• MDR Text Key: 75372865
• Report Number: 0001032347-2017-00382
• Device Sequence Number: 1
• Product Code: HXX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PN/A
• 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: 05/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: N/A
• Device Catalogue Number: 24-1188
• Device Lot Number: UNKNOWN
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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