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

Model Number 912076

Device Problem Difficult or Delayed Activation (2577)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/08/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Foreign- (b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the transparent plastic sleeve did not slide properly for four anchors out of five, but succeeded in placing four anchors properly except one anchor that failed to deploy.No adverse event has been reported as a result of the malfunction.

Event Description

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

Manufacturer Narrative

Complaint sample was evaluated and the reported event was confirmed.Visual examination of the returned product identified that the tip of the juggerknot was fractured.It was sent to scanning electron microscopy (sem) for further testing.Fractography conducted by sem revealed the mode of failure, suspected crack initiation, and crack exit sites on the juggerknot inserter tip fractured samples.Fractography conducted on juggerknot inserter tip fractures using sem revealed that it was fractured due to bending overload.Energy-dispersive x-ray spectroscopy (eds) semi-quantitative elemental analysis confirmed that the inserter tip material to be consistent with nitinol alloy.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to 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: FASTENER, FIXATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11689360
• MDR Text Key: 251714792
• Report Number: 0001825034-2021-01148
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 00880304520820
• UDI-Public: (01)00880304520820(17)251117(10)836210
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 09/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 912076
• Device Catalogue Number: 912076
• Device Lot Number: 836210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1