MAUDE Adverse Event Report: BIOMET TRAUMA 3.5MM CORT LOCK SCR 40MM NS; PLATE, FIXATION, BONE

Model Number N/A

Device Problems Difficult to Remove (1528); Separation Failure (2547)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/17/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).The product identification necessary to review manufacturing history was not provided.Current information is insufficient to permit a conclusion as to the cause of the event.It is unknown if the screw was removed in the (b)(6) 2017 procedure.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2016-05039-1, 03672, 03673, 03674, 03677, 03678, 03679, and 03680.

Event Description

It was reported that during removal of a right proximal tibial plate approximately twenty-two months post-implantation, it was found that some of the screws were stripped and some of the locking screws were cold welded to the plate.Ultimately, the plate and one screw were left implanted in the patient, as they were unable to complete the removal.

• Brand Name: 3.5MM CORT LOCK SCR 40MM NS
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): BIOMET TRAUMA; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6620712
• MDR Text Key: 76942597
• Report Number: 0001825034-2017-03678
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: PK143697
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2017
• 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: 816135040
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/10/2017
• 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: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention