MAUDE Adverse Event Report: BIOMET MICROFIXATION LORENZ IMF SCREW; SCREW, FIXATION, INTRAOSSEOUS; 2.0 X 9MM SELF DRILLING IMF HEX SCREW

Model Number N/A

Device Problem Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/18/2017

Event Type  Injury  

Manufacturer Narrative

The warnings in the package insert state this type of event can occur.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

The facility medwatch report (b)(4) was received which states "during open reduction internal fixation of left mandibular fracture, surgeon inserted imf 2.0x9mm screw into mandible and the top of the screw fractured." additional information was requested and the following response was received: the top/head of the screw was discarded in sharp containers at the time of the event and the lower piece of the screw was retained in the left mandible as expected; the surgery was completed without delay.Catalog number was confirmed by the facility contact.

• Brand Name: LORENZ IMF SCREW
• Type of Device: SCREW, FIXATION, INTRAOSSEOUS; 2.0 X 9MM SELF DRILLING IMF HEX 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: 6698010
• MDR Text Key: 79523053
• Report Number: 0001032347-2017-00544
• Device Sequence Number: 1
• Product Code: DZL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK983728
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2017
• 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: 91-5609
• Device Lot Number: UNKNOWN
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other
• Patient Age: 26 YR