MAUDE Adverse Event Report: BIOMET TRAUMA DVR ANATOMIC NARROW SHORT WITH F.A.S.T. GUIDE INSERTS; PLATE, FIXATION

Model Number N/A

Device Problem Bent (1059)

Patient Problem Bone Fracture(s) (1870)

Event Date 04/26/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Unique identifier - (b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the patient underwent a distal radius fracture plating procedure and was revised approximately 3 months post-implantation due to a patient bone fracture.Upon explantation, it was noted that the fracture plate was deformed.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

Upon reassessment of the reported event, it was determined to not be reportable.A revision has been indicated due to patient falling causing the fracture (per the surgeon) and is not related to a product issue.

• Brand Name: DVR ANATOMIC NARROW SHORT WITH F.A.S.T. GUIDE INSERTS
• Type of Device: PLATE, FIXATION
• 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: 6591584
• MDR Text Key: 75979972
• Report Number: 0001825034-2017-03401
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PK111663
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 131212010
• Device Lot Number: 714170
• Other Device ID Number: SEE NARRATIVE IN H10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/05/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/06/2016
• 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