MAUDE Adverse Event Report: ZIMMER BIOMET, INC. JUGGERKNOT DISP KIT 1.5MM; ORTHOPAEDIC SURGICAL PROCEDURE KIT, NON-MEDICATED, SINGLE-USE

Catalog Number 912041

Device Problem Fracture (1260)

Patient Problem No Patient Involvement (2645)

Event Date 10/12/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Event Description

It was reported that the drill bit fractured in junction with drill.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.D4: (b)(4) no product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing.A definitive root cause cannot 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 is available at the time of this report.

• Brand Name: JUGGERKNOT DISP KIT 1.5MM
• Type of Device: ORTHOPAEDIC SURGICAL PROCEDURE KIT, NON-MEDICATED, SINGLE-USE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10778775
• MDR Text Key: 214382635
• Report Number: 0001825034-2020-03912
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• PMA/PMN Number: K150768
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 12/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 912041
• Device Lot Number: 612140
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1