MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FIB ANATOMIC LOCK RT 3H STE ROD, FIXATION

Model Number 8562-07-003

Device Problem Packaging Problem (3007)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/16/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4). Foreign- (b)(6). 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 during the inspection at the warehouse, that a scratch was found on the sterile package. There was no patient involvement.

• Brand Name: FIB ANATOMIC LOCK RT 3H STE
• Type of Device: ROD, 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: 12125916
• Report Number: 0001825034-2021-01875
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 00887868061998
• UDI-Public: (01)00887868061998
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K111663
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 8562-07-003
• Device Catalogue Number: 856207003
• Device Lot Number: 789220R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2021

Is the Reporter a Health Professional?

• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 09/28/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/14/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial