MAUDE Adverse Event Report: ZIMMER BIOMET PIN, FIXATION, THREADED

Model Number 110028879 705450

Device Problems Loose or Intermittent Connection (1371); Migration or Expulsion of Device (1395)

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

Event Date 09/12/2016

Event Type  malfunction  

Event Description

Pt underwent a reverse total arthroplasty of the left shoulder, completed therapy and was doing well.At his post-op visit, a radio-opaque element was seen in the post-op shoulder x-ray.After investigation, it is suspected to be a pin from a biomet instrument used in the procedure.The instrument is biomet 110028879 705450.It is suspected that the pin that is soldered at the base of the black plastic plunger may have loosened and fallen in to the pt's shoulder during the procedure.This instrument receives significant force as it is struck with a metal mallet.The pt is doing well at this time and has not decided on re-operation to remove the pin.

• Brand Name: PIN, FIXATION, THREADED
• Type of Device: PIN, FIXATION, THREADED
• Manufacturer (Section D): ZIMMER BIOMET; warsaw IN 46580
• MDR Report Key: 6409090
• MDR Text Key: 70265476
• Report Number: MW5068463
• Device Sequence Number: 1
• Product Code: JDW
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 110028879 705450
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 83 YR
• Patient Weight: 78