MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PEG SMOOTH 2.0X18MM; PLATE, FIXATION

Catalog Number P18000

Device Problem Positioning Problem (3009)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/28/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2017-03676, and 0001825034-2017-03675.Complaint sample was evaluated and the reported event was not confirmed.The pegs were returned and a visual examination was conducted.There are remnants of material in the threads confirming attempted use.There is some pitting, wear, and discoloration to the threads closest to the shank of the peg.There is some discoloration on the smooth part of the pegs likely from the attempted implantation.There is no noticeable damage to the peg heads that would have contributed to the pegs not threading into the plate.Since the plate was not returned and some damage is noted on the lower threads, functional testing of the pegs cannot be performed.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.There are warnings in the package insert that this type of event can occur and risks are addressed in risk documentation.However, without the opportunity to examine the complaint product, root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after the investigation of this event.Zimmer biomet will continue to monitor for trends.

Event Description

It is reported that during a distal volar radius trauma fixation plating procedure, the surgeon was unable to get the pegs to lock into the plate, delaying the surgery ten (10) minutes.He used multi-directional screws to complete the procedure.No adverse events were reported as a result of this malfunction.

• Brand Name: PEG SMOOTH 2.0X18MM
• 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: 7162193
• MDR Text Key: 96814714
• Report Number: 0001825034-2018-00026
• Device Sequence Number: 1
• Product Code: LXT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK050932
• 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
• Report Date: 01/03/2018

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: P18000
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/22/2017
• Initial Date FDA Received: 01/03/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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