MAUDE Adverse Event Report: BIOMET MICROFIXATION TWIST DRILL 1.7X50MM 9MM STP J-NT

Model Number N/A

Device Problem Material Discolored (1170)

Patient Problem No Code Available (3191)

Event Date 11/22/2016

Event Type  Injury  

Manufacturer Narrative

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.There are two potential lot numbers 780180 and 819770; the device history records were reviewed and no non conformances were identified.(b)(4).Report one of two for the same event; reference report 0001032347-2017-00004.

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 one of two for the same event.Report two of two is reported on mfr #0001032347-2017-00004.

Manufacturer Narrative

The twist drill was viewed under a digital microscope and showed no signs of black, but it did have some dried blood on the tip and near the stop; therefore the complaint is not confirmed.The most likely underlying cause of this complaint cannot be determined as there is no black discoloration on the twist drill.Supplemental report one of two for the same event, reference report 0001032347-2017-00004-2.

• Brand Name: TWIST DRILL 1.7X50MM 9MM STP J-NT
• Type of Device: TWIST DRILL
• 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: 6221719
• MDR Text Key: 63838826
• Report Number: 0001032347-2017-00003
• Device Sequence Number: 1
• Product Code: HBE
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PK062842
• 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

• Date FDA Received: 01/04/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 915-1729
• Device Lot Number: UNKNOWN
• Other Device ID Number: SEE H10 NARRATIVE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/18/2013
• 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): Hospitalization; Other