MAUDE Adverse Event Report: BIOMET MICROFIXATION LORENZ RESORBABLE DISTRACTOR SYSTEM; LACTOSROB SCREW 1.5 X 6 MM

Model Number N/A

Device Problems Material Discolored (1170); Device Inoperable (1663)

Patient Problem No Code Available (3191)

Event Date 11/22/2016

Event Type  Injury  

Manufacturer Narrative

Review of device history records show the lot released with no recorded anomaly or deviation.The user facility is foreign; therefore a facility medwatch report will not be available.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.Report two of two for the same event; reference report 0001032347-2017-00003.

Event Description

It is reported during an open reduction procedure the twist drill was used for forehead cheekbone suture and the screws were used for the infraorbital margin.The twist drill was not inserted well and both the twist drill and the patient's bone turned black.Additionally, one of the screws turned white near the middle of the screw and after spinning once the screw would no longer spin.The surgeon commented the screw seemed soft.A surgical delay in excess of 30 minutes was reported, however the exact duration of the delay is unknown.The surgery was completed using devices available, no details regarding these devices are known at this time.

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 two of two for the same event.Report one of two is reported on mfr #0001032347-2017-00003.

Manufacturer Narrative

The returned screw was viewed under a digital microscope, the screw showed minimal signs of use on the hexhead and threads.The screw was functionally tested by inserting it into a white oak wood block with a tapped 1.5mm hole.The screw fully seated into the white oak wood block.The most likely underlying cause of this complaint cannot be determined as the screw functioned as intended.There are no indications of a manufacturing defect.Supplemental report two of two for the same event; reference report 0001032347-2017-00003-2.

• Brand Name: LORENZ RESORBABLE DISTRACTOR SYSTEM
• Type of Device: LACTOSROB SCREW 1.5 X 6 MM
• 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: 6221728
• MDR Text Key: 63838800
• Report Number: 0001032347-2017-00004
• Device Sequence Number: 1
• Product Code: JEY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PK002083
• 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: 12/07/2016

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 Expiration Date: 10/01/2018
• Device Model Number: N/A
• Device Catalogue Number: 915-2317
• Device Lot Number: 882280
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/07/2016
• Initial Date FDA Received: 01/04/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/17/2017; 02/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/14/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other