MAUDE Adverse Event Report: ZIMMER BIOMET, INC. JGRKNT 1.0MM MINI 3-0 NDLS; FASTENER, FIXATION

Catalog Number 912082

Device Problems Fracture (1260); Material Deformation (2976)

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

Event Date 07/21/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(b)(4).Report source: (b)(6).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported during visual inspection that the nitinol tip was fractured and the clear sleeve was damaged.No adverse event has been reported as a result of the malfunction.

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.D4 - udi #: (b)(4).Visual examination of the returned product identified the instrument was fractured.For some reason the tip of the sleeve is bent.Product sent to scanning electron microscopy (sem) for analysis: energy dispersive x-ray spectroscopy (eds) semi-quantitative elemental analysis confirmed that the inserter tip material to be consistent with nitinol alloy.It has been confirmed that tip fractured due to bending overload.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined.A summary of the investigation has been sent to the complainant.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 3-0 NDLS
• Type of Device: FASTENER, FIXATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10563632
• MDR Text Key: 207906352
• Report Number: 0001825034-2020-03513
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• PMA/PMN Number: K140908
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 12/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 912082
• Device Lot Number: 282440
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1