MAUDE Adverse Event Report: ZIMMER INC ZIMMER BIOMET STERILE WIRE PIN; PIN, FIXATION, SMOOTH

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 05/25/2021

Event Type  malfunction  

Event Description

Sterile pins were placed to hold a cutting guide in place while using a saw.After cutting guide was used pins were removed but a piece of the sterile pin had broke off and remained embedded in the bone.Zimmer wire pin start (b)(6) 2021, end date (b)(6) 2021.Fda safety report id # (b)(4).

• Brand Name: ZIMMER BIOMET STERILE WIRE PIN
• Type of Device: PIN, FIXATION, SMOOTH
• Manufacturer (Section D): ZIMMER INC
• MDR Report Key: 11991636
• MDR Text Key: 256449521
• Report Number: MW5101860
• Device Sequence Number: 1
• Product Code: HTY
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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: 76 YR