MAUDE Adverse Event Report: BIOMET MICROFIXATION 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 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.

Event Description

It was reported a right angle driver that stopped working during a ribfix procedure.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.There was no patient injury and no surgical delay as another driver was available to complete the surgery.

Manufacturer Narrative

The product could not be located for an evaluation.Therefore, the product identity could not be confirmed and the complaint could not be verified.Based on the description of the malfunction provided by the sales associate, the development engineers determined the most-likely cause of the complaint to be excessive torque applied to the driver.

Manufacturer Narrative

This report was submitted to correct the device product code and 510(k) number.The following sections were corrected: (b)(4).

Event Description

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

• Brand Name: 90 DEG CONTRA ANGLE SCREWDRIVER
• 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: 6028271
• MDR Text Key: 57403931
• Report Number: 0001032347-2016-00577
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/07/2018

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: 114620
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/13/2016
• Initial Date FDA Received: 10/13/2016
• Supplement Dates Manufacturer Received: Not provided; 11/29/2018
• Supplement Dates FDA Received: 12/30/2016; 12/07/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/14/2014
• 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