MAUDE Adverse Event Report: BIOMET ORTHOPEDICS DYNAMIC COMP PLATE SS 9 HOLE; FIXATION, PLATE

Model Number N/A

Device Problem Bent (1059)

Patient Problems Fall (1848); Bone Fracture(s) (1870)

Event Date 12/15/2015

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: under possible adverse effects, number 2 states, "bending or fracture of the implant." number 10 states, "intraoperative or postoperative bone fracture and/or postoperative pain".

Event Description

It was reported a patient underwent a femoral fixation procedure on an unknown date in (b)(6) 2015.Subsequently, the patient was revised on (b)(6) 2015 due to femoral fracture and bent plate.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.Examination of returned device found no evidence of product non-conformance.During the evaluation, the plate showed evidence of bending.Root cause of the event was most likely attributed to the patient falling causing excessive force on the implant; however, a conclusive root cause could not be determined.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 2 states, "bending or fracture of the implant.

Event Description

It was reported a patient underwent a femoral fixation procedure on (b)(6) 2015.The patient experienced a fall on (b)(6) 2015.Subsequently, the patient was revised on (b)(6) 2015 due to femoral fracture and bent plate.

• Brand Name: DYNAMIC COMP PLATE SS 9 HOLE
• Type of Device: FIXATION, PLATE
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: megan haas ; 56 e. bell drive; warsaw, IN 46582 ; 5743726700
• MDR Report Key: 5506925
• MDR Text Key: 40539382
• Report Number: 0001825034-2016-00920
• Device Sequence Number: 1
• Product Code: JDQ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: PK982545
• 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: 03/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2016
• 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: 350819
• Device Lot Number: 643840
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/08/2014
• 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; Required Intervention
• Patient Weight: 60