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

Model Number N/A

Device Problem Mechanical Jam (2983)

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

Event Date 11/11/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source: event occurred in (b)(6).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported the sheaths did not slide as expected during insertion.The surgery was completed with another device.No further information has been made available at the time of this reporting.

Event Description

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

Manufacturer Narrative

Upon reassessment of the reported event it was determined that the device malfunction was not did not cause any serious injury in the past and is not reportable.The initial report was submitted in error hence needs to be voided.

• Brand Name: JGRKNT 1.0MM MINI 2-0 NDLS
• Type of Device: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9377820
• MDR Text Key: 203518628
• Report Number: 0001825034-2019-05218
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 00880304520820
• UDI-Public: (01)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: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 02/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 912076
• Device Lot Number: 053190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/13/2019
• Initial Date FDA Received: 11/26/2019
• Supplement Dates Manufacturer Received: 02/12/2020
• Supplement Dates FDA Received: 02/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: 912076 JUGGERKNOT MINI 2-0, LOT 053190.