MAUDE Adverse Event Report: ZIMMER BIOMET, INC. DVR ANATOMIC STANDARD HEAD RIGHT; PLATE, FIXATION

Model Number N/A

Device Problem Difficult To Position (1467)

Patient Problem No Information (3190)

Event Date 09/15/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products- unknown locking pegs, cat#: ni lot#: ni.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 during a distal volar radius trauma plating procedure, two locking pegs would not lock into the distal holes on the wrist plate.The plate had to be removed and a new plate was utilized with the same locking pegs.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

(b)(4).This follow-up report is being filed to relay additional information which was unknown at the time of the initial medwatch.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.Visual examination finds that there is damage to the threads of distal holes, likely from the attempts to lock the pins as reported.Functional or dimensional analysis could not be conducted, due to the damage to the threads.Device history record was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required as no trends were identified.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: DVR ANATOMIC STANDARD HEAD RIGHT
• Type of Device: PLATE, FIXATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6958032
• MDR Text Key: 89680043
• Report Number: 0001825034-2017-09099
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK111663
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2017
• 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: DVRAR
• Device Lot Number: RM369G
• Other Device ID Number: SEE H10 NARRATIVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2015
• 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