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

Model Number N/A

Device Problem Difficult To Position (1467)

Patient Problem No Information (3190)

Event Date 03/28/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: mfr#0001825034-2018-02327, mfr#0001825034-2018-02329.Reported event was unable to be confirmed due to limited information received from the customer.Device history record was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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

It was reported that, during a left ankle fracture repair, the surgeon was unable to seat the implant flush onto the fibula.The surgeon attempted three different devices, requiring additional drilling each time, and experienced the same problem.The surgeon completed the procedure using an alternate zimmer biomet device.A 30-45 minute delay in surgery occurred.Attempts have been made and additional information on the reported event is unavailable.

• Brand Name: JUGGERLOC BONE TO BONE IMPLANT
• Type of Device: WASHER, BOLT
• 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: 7397471
• MDR Text Key: 104406924
• Report Number: 0001825034-2018-02328
• Device Sequence Number: 1
• Product Code: HTN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK141219
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 02/22/2023
• Device Model Number: N/A
• Device Catalogue Number: 110007345
• Device Lot Number: 294410
• Other Device ID Number: (01) 0 0880304 68032 6
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/28/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/22/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention