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 Type  malfunction  

Manufacturer Narrative

Without a product return, no product evaluation is able to be conducted.The lot number is unknown; therefore the device history records are unable to be reviewed.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.

Event Description

It was reported the surgeon was attempting to seat a screw, as he turned the knob on the driver a "clicking" sound could be heard however it had no torque.It was confirmed the driver was correctly on the head of the screw, however it still did not torque.There was no surgical delay or injury to the patient; the surgeon used the second driver to complete the surgery.

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.

Manufacturer Narrative

The product identity was confirmed in the evaluation.The device history records were reviewed for the lot and no non-conformances were found.The driver was visually evaluated and it shows signs of normal use.The complaint was confirmed as when the handle (knob) was rotated an inserted blade did not rotate.It was noticed that the head of the driver was a little loose and able to be screwed back into the handle.The loose head would cause the hex not to engage properly.After this, when the knob was rotated an inserted blade would rotate.The driver was then tested with a blade, a screw, and poplar.The blade could be successfully inserted into the driver.The screw was inserted and removed from the poplar with no issues.The complaint is confirmed as upon receipt the driver would not turn a blade.The most likely underlying cause of the complaint was determined to be loosening of the head from the handle.

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: 6247425
• MDR Text Key: 64722810
• Report Number: 0001032347-2017-00032
• 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,Followup
• Report Date: 12/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2017
• 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: 490190
• Other Device ID Number: (01)00841036123130(10)490190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2017
• 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: 06/15/2015
• 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