MAUDE Adverse Event Report: ZIMMER BIOMET, INC. STERILE TRAC SYSTEM THREE LONG DOG BONE SET; PLATE, FIXATION, BONE

Catalog Number 15-7378X

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Reaction (2414)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source: foreign: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up report will be submitted.

Event Description

It was reported that the patient had a severe reaction after the initial procedure.No revision procedure has been reported at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.

Event Description

This follow-up report is being submitted to relay additional information.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.The patient was inquiring to find out what the plates are made of.It was determined that item# 15-7378x includes plate item# 01-7347-01 and screw item# 91-6104-01.This plate is made from material cp titanium grade ii astm f-67.This screw is made from ti-6al-4v astm f136.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No further event information available at the time of this report.

• Brand Name: STERILE TRAC SYSTEM THREE LONG DOG BONE SET
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10400834
• MDR Text Key: 202687726
• Report Number: 0001825034-2020-03157
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• PMA/PMN Number: K972322
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/06/2022
• Device Catalogue Number: 15-7378X
• Device Lot Number: 166410
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other