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 02/23/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant medical products: part# 912076 cat# 839930 jgrknt 1.0mm mini 2-0 ndls.Report source foreign- (b)(6).Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2021 - 00851.

Event Description

It was reported by the surgeon that two juggerknots failed to deploy during the procedure.No patient harm has been reported as a result of this event.

Event Description

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

Manufacturer Narrative

Cmp-(b)(4).Reported event was unable to be confirmed due to limited information received from the customer.Device history record was reviewed and no discrepancies relevant to the reported event were found.A definitive 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: FASTENER, FIXATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11627063
• MDR Text Key: 246793577
• Report Number: 0001825034-2021-00850
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 00880304520820
• UDI-Public: (01)00880304520820(17)251113(10)839930
• 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: 05/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2021
• 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: 839930
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1