MAUDE Adverse Event Report: BIOMET ORTHOPEDICS DISTAL VOLAR RADIUS PLATING SYSTEMS - DVR LOCK; APPLIANCE, FIXATION

Catalog Number 131821040

Device Problem Component Missing (2306)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint device has not been returned, but the device investigation has not yet been completed.Once the evaluation is completed, a supplemental medwatch 3500a will be completed.

Event Description

It was reported that plate was not inside package and it was sealed.No adverse events have been reported as a result of the malfunction.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Product was not returned.The device history record was reviewed and no discrepancies were found.Review of the complaint history determined that no further actions is required.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: DISTAL VOLAR RADIUS PLATING SYSTEMS - DVR LOCK
• Type of Device: APPLIANCE, FIXATION
• 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: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6648845
• MDR Text Key: 77841910
• Report Number: 0001825034-2017-04106
• Device Sequence Number: 1
• Product Code: LXT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK112345
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 02/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 131821040
• Device Lot Number: J3978538
• Other Device ID Number: (01) 0 0880304 53343 1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/17/2017
• Initial Date FDA Received: 06/16/2017
• Supplement Dates Manufacturer Received: 02/10/2018
• Supplement Dates FDA Received: 02/10/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1