MAUDE Adverse Event Report: BIOMET MICROFIXATION 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 Date 02/06/2017

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.

Event Description

It is reported the internal mechanism of the contra angle driver broke and the wheel no longer rotated the blade.The additional contra angle driver in the set was used to complete the surgery.There was a twenty minute delay.The distributor associate stated the resident who was using the driver was not turning the wheel over extensively.

Manufacturer Narrative

The product was returned in a biohazard bag and therefore could not be functionally tested.The product handle was turned through the bag and no resistance was felt.The most likely cause of the of the complaint could not be determined.

Manufacturer Narrative

This report was submitted to correct the device product code and 510(k) number.The following sections were corrected: device product code: jey corrected to hrs.Pma/510(k) number: k121589 corrected to k142823.

Event Description

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

• Brand Name: 90 DEGREE CONTRA ANGLE SCREWDRIVER
• Type of Device: 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: 6381101
• MDR Text Key: 69168655
• Report Number: 0001032347-2017-00169
• 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: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2017
• 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: 056380
• Other Device ID Number: (01)00841036123130(10)056380
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/29/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/12/2016
• 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