MAUDE Adverse Event Report: ZIMMER BIOMET, INC. JUGGERLOC BONE TO BONE TI KIT; WASHER, BOLT

Model Number N/A

Device Problem Component Missing (2306)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/01/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as there was no device in the packaging.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.(b)(4).

Event Description

It was reported that during an ankle syndesmosis procedure, when the packaging was opened, there was no product in the sealed box.This was found prior to use in a surgery.There were no patient consequences as a result of the malfunction.Attempts have been made and no further information has been provided.

Manufacturer Narrative

Reported event was confirmed by review of pictures.The provided photo showed that no device was in the packaging.Device history record (dhr) was reviewed and no discrepancies were found.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.

Event Description

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

• Brand Name: JUGGERLOC BONE TO BONE TI KIT
• Type of Device: WASHER, BOLT
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8129089
• MDR Text Key: 129197785
• Report Number: 0001825034-2018-10812
• Device Sequence Number: 1
• Product Code: HTN
• Combination Product (y/n): N
• PMA/PMN Number: K141219
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 03/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/25/2023
• Device Model Number: N/A
• Device Catalogue Number: 110007345
• Device Lot Number: 329820
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/08/2018
• Initial Date FDA Received: 12/04/2018
• Supplement Dates Manufacturer Received: 03/21/2019
• Supplement Dates FDA Received: 03/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1