MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 3.5X16MM CORT LOCK SCR STE; PLATE, FIXATION

Model Number N/A

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Patient Involvement (2645)

Event Date 06/28/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Unique identifier (udi) #: n/a.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 that during incoming inspection, a team member found debris in the sterile package.No adverse events occurred as a result of this malfunction, as it had no patient involvement.

Manufacturer Narrative

Upon further review it was found that this device is not reportable as it was incorrectly reported the first time.The description should be ¿the perforations were torn off¿ the previously reported ¿debris in the sterile package.¿ therefore, this product is not reportable and the initial subform should be voided.

• Brand Name: 3.5X16MM CORT LOCK SCR STE
• Type of Device: PLATE, FIXATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7778842
• MDR Text Key: 117138933
• Report Number: 0001825034-2018-04786
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• PMA/PMN Number: PK111663
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 10/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 856135016
• Device Lot Number: 775330
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1