MAUDE Adverse Event Report: BIOMET TRAUMA TI-DBLE LEAD CORT 5.0X40MM SCR; FIXATION, ROD

Model Number N/A

Device Problems Break (1069); Material Erosion (1214)

Patient Problem No Information (3190)

Event Date 02/01/2016

Event Type  Injury  

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show that lot released with no recorded anomaly or deviation.There are warnings in the package insert that state that this type of event can occur.

Event Description

It was reported during an ankle arthrodesis procedure on (b)(6) 2016, the screw for the distal anteroposterior hole interfered with the locking mechanism and the screw was not fastened while another screw was being inserted in to the system.The screw was removed and noted to be damaged and worn.Another screw was used to complete the procedure.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.(b)(4).Examination of returned device found no evidence of product non-conformance.Review of the device confirmed the reported condition.Striped threads were noted during the evaluation.The most likely root cause for the event was due to the mating mechanism being out of place, or the targeting jig being misaligned.

• Brand Name: TI-DBLE LEAD CORT 5.0X40MM SCR
• Type of Device: FIXATION, ROD
• Manufacturer (Section D): BIOMET TRAUMA; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): BIOMET TRAUMA; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: megan haas ; 56 e. bell drive; warsaw, IN 46582 ; 5743726700
• MDR Report Key: 5460648
• MDR Text Key: 39029403
• Report Number: 0001825034-2016-00637
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PK063570
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/14/2016

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?: No
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 14-405040
• Device Lot Number: 443920
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/01/2016
• Initial Date FDA Received: 02/25/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/25/2015
• 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): Required Intervention