MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN JUGGERKNOT DRILL

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/16/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint cannot be confirmed as the medical records or and complaint sample was not returned for evaluation.Review of device history records cannot be reviewed as product information was limited.A root cause cannot be identified based on the available information.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2018 - 08818.

Event Description

It was reported that during the procedure, after drilling the hole for the implant, the anchor could not be seated into the bone.It was alleged that the drilled hole was too small, possibly causing the issue with the anchor not seating properly.No patient consequences were reported as a result of the malfunction.No additional information is made available.

• Brand Name: UNKNOWN JUGGERKNOT DRILL
• Type of Device: DRILL
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8117392
• MDR Text Key: 128902682
• Report Number: 0001825034-2018-10968
• Device Sequence Number: 1
• Product Code: HTW
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/13/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1