MAUDE Adverse Event Report: BIOMET MICROFIXATION 2.0 X 5 MM HIGH TORQUE CROSS-DRIVE SCREW; BONE SCREW

Model Number N/A

Device Problem Device Inoperable (1663)

Patient Problem No Code Available (3191)

Event Date 08/23/2016

Event Type  Injury  

Manufacturer Narrative

The warnings in the package insert state this type of event can occur.The user facility is foreign; therefore a facility medwatch report will not be available.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 "during an upper jaw surgery, the screw could not be retained." it is confirmed that the screw was inserted into the bone and then removed.The surgeon inserted a different screw with the same part number inside the same hole to complete the surgery.It is reported that there was no foreign body retained and no delay over 30 minutes long.

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 was returned without its original packaging.The product was visually evaluated with a digital microscope.According to the evaluation, from the tip and side views, the flutes and threads still appear to be sharp with a white residue present - indicative of use.According to the evaluation, the top view shows damage across threads on the head of the screw.The product was functionally tested and found to function as intended, therefore the complaint is not confirmed.The most likely cause for the complaint was determined to be improper technique.

• Brand Name: 2.0 X 5 MM HIGH TORQUE CROSS-DRIVE SCREW
• 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: 6003396
• MDR Text Key: 56591557
• Report Number: 0001032347-2016-00552
• Device Sequence Number: 1
• Product Code: JEY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PK121589
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 09/06/2016

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: 91-2005
• Device Lot Number: UNKNOWN
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/06/2016
• Initial Date FDA Received: 10/06/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 10/14/2016; 11/16/2016
• 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: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention