MAUDE Adverse Event Report: ZIMMER BIOMET, INC. JGRKNT 1.0MM MINI 2-0 NDLS; FASTNER, FIXATION

Model Number N/A

Device Problem Failure to Discharge (1169)

Patient Problem No Information (3190)

Event Date 08/27/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source: (b)(6).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Not returned to manufacturer.

Event Description

It was reported the juggerknot would not anchor.The process had to be repeated causing a 35 minute delay to surgery.No further information is available at the time of this reporting.

Event Description

No further information is available at the time of this reporting.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.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.

• Brand Name: JGRKNT 1.0MM MINI 2-0 NDLS
• Type of Device: FASTNER, FIXATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9069627
• MDR Text Key: 158805128
• Report Number: 0001825034-2019-04124
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 00880304520820
• UDI-Public: 00880304520820
• Combination Product (y/n): N
• PMA/PMN Number: K110879
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 11/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/11/2024
• Device Model Number: N/A
• Device Catalogue Number: 912076
• Device Lot Number: 862520
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/27/2019
• Initial Date FDA Received: 09/16/2019
• Supplement Dates Manufacturer Received: 10/23/2019
• Supplement Dates FDA Received: 11/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention