MAUDE Adverse Event Report: BIOMET MICROFIXATION 1.5 X 4 MM HIGH TORQUE SELF-DRILLING CROSS-DRIVE SCREW EACH; BONE SCREW

Model Number N/A

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

Patient Problem No Code Available (3191)

Event Type  Injury  

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.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 is reported that a screw was implanted into a bone, but was stuck in an unknown blade of an iq driver.Therefore, the screw had to be removed from the bone with the blade attached.It is reported the surgeon completed the procedure with another screw and iq blade.It is reported that no shaving of the bone took place during this event.It is reported the event did not result in a delay of more than thirty minutes.

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.This is report one of two for the same event.Report two of two is reported on mfr #0001032347-2017-00043.

Manufacturer Narrative

The product identities were confirmed in the evaluation.Both parts were visually evaluated and seen to have signs of normal use as well as patient tissue and blood from use.The blade had considerable amount of blood and material on the cross drive blades.The blade and screw were functionally tested by inserting the screw into white oak using an iq driver.The screw was easily inserted into the block and the blade was easily removed from the screw head.The complaint couldn't not be confirmed.The most likely cause of the complaint can not be determined as the reported event was not recreated.Potentially incorrect technique with disengaging the screw from the blade was used.Instructions for use state in the warnings section, "the surgeon must be thoroughly knowledgeable not only in the medical and surgical aspects of the implant, but also must be aware of the mechanical and metallurgical aspects of the surgical implants." this is report one of two for the same event.Report two of two is reported on mfr #0001032347-2017-00043.

• Brand Name: 1.5 X 4 MM HIGH TORQUE SELF-DRILLING CROSS-DRIVE SCREW EACH
• Type of Device: BONE SCREW
• 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: 6254281
• MDR Text Key: 64885084
• Report Number: 0001032347-2017-00041
• Device Sequence Number: 1
• Product Code: JEY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK121589
• 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: 01/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 91-6104
• Device Lot Number: UNKNOWN
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/05/2017
• Initial Date FDA Received: 01/16/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/30/2017; 04/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention