MAUDE Adverse Event Report: BIOMET MICROFIXATION 90 DEGREE CONTRA ANGLE SCREWDRIVER

Model Number N/A

Device Problem Device Operational Issue (2914)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/21/2016

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.Report two of two for the same event, reference 0001032347-2017-00044.

Event Description

It was reported during a thoracotomy for lung resection and rib fixation two drivers did not turn adequately.It was reported the drivers were able to be used though the end of the surgery.There was no surgical delay or injury to the patient.

Manufacturer Narrative

The product identities were confirmed in the evaluation.The drivers were visually evaluated and they show signs of normal use.The drivers were tested with a blade, a screw, and poplar.The blade could be successfully inserted into the drivers.The screw could be inserted into the poplar, but the drivers both had choppy movement.They stick at multiple points throughout the rotation.The drivers were disassembled and the internal components were evaluated.It was noticed that the horizontal internal shaft had a slight eccentric motion which would explain the sticking at one point in the rotation.The bent shaft likely occurred from excessive force applied to the driver, causing deflection in the shaft.This would occur if the screw was fully seated and force was continued to be applied.The gears would tend to deflect away from each other in a direction perpendicular to the axis of rotation.The complaint was confirmed as the drivers have a choppy operation during use.The drivers were able to insert a screw and perform its function.The most likely underlying cause was determined to be excessive force applied to the driver.This is report two of two for the same event.Report one of two is reported on mfr #0001032347-2017-00044.

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: 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: 6254432
• MDR Text Key: 64931568
• Report Number: 0001032347-2017-00045
• 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,health profession
• Reporter Occupation: Physician
• 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

• Date FDA Received: 01/16/2017
• 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: 306850
• Other Device ID Number: (01)00841036123130(10)306850
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/29/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/07/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1