MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PEG FULLY THREAD; PLATE, FIXATION

Model Number N/A

Device Problem Device Packaging Compromised (2916)

Patient Problem No Patient Involvement (2645)

Event Date 02/28/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Reporter had indicated that product will be returned.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filled for this event: 0001825034-2018-02229.

Event Description

It was reported that a hole was found on the sterile packaging during receiving inspection.There was no patient involvement.

Manufacturer Narrative

This follow-up report is being submitted to relay additional and corrected information.The complaint sample was evaluated and the reported event was confirmed through visual inspection.The returned packaging confirmed that holes were present.The device history records were reviewed and no discrepancies were identified.Based on the information provided, a definitive root cause could not be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: PEG FULLY THREAD
• Type of Device: PLATE, 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: 7379381
• MDR Text Key: 103937087
• Report Number: 0001825034-2018-02231
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PK081546
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 06/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2018
• 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: 131212628
• Device Lot Number: 801240
• Other Device ID Number: (01) 00887868012402
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/25/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/14/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1