MAUDE Adverse Event Report: ZIMMER BIOMET, INC. JUGGERLOC BONE-TO-BONE STAINLESS STEEL ROUND BUTTON WITH SOLID DRILLS KIT; WASHER, BOLT

Model Number N/A

Device Problem Expulsion (2933)

Patient Problem No Information (3190)

Event Date 07/30/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2018 - 08571.

Event Description

It was reported that during am ankle syndesmosis repair procedure, upon tightening the button down to the plate, the juggerloc implant pulled out of the bone.The patient's bone was re-drilled and second kit was attempted to be implanted, but this anchor also pulled out of the bone.Surgery was successfully completed with competitor's screw.No additional patient consequences were reported.

Manufacturer Narrative

(b)(4).Reported event was unable to be confirmed due to limited information received from the customer.Dhr was reviewed and no discrepancies 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

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

• Brand Name: JUGGERLOC BONE-TO-BONE STAINLESS STEEL ROUND BUTTON WITH SOLID DRILLS KIT
• Type of Device: WASHER, BOLT
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7836138
• MDR Text Key: 118868584
• Report Number: 0001825034-2018-08570
• Device Sequence Number: 1
• Product Code: HTN
• Combination Product (y/n): N
• PMA/PMN Number: PK141219
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/21/2023
• Device Model Number: N/A
• Device Catalogue Number: 110007337
• Device Lot Number: 294370
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: 110007337,JUGGERLOC STAINLESS,378800; 110007337,JUGGERLOC STAINLESS,378800
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR
• Patient Weight: 116