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

Model Number N/A

Device Problems Fracture (1260); Mechanical Jam (2983)

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

Event Date 09/24/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Udi#: (b)(4).Concomitant medical products: item# 912076; jgrknt 1.0mm mini 2-0ndls; lot# 697500.Item# 912076; jgrknt 1.0mm mini 2-0ndls; lot# 697500.Item# 912076; jgrknt 1.0mm mini 2-0ndls; lot# 273440.Report source: foreign (b)(4).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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2019-04497, 0001825034-2019-04498, 0001825034-2019-04499.

Event Description

It was reported that during a surgery, the plastic sleeve on the inserter handle of the mini juggerknot was too tight and would not slide.Additionally, when it was inserted, the tip broke and the anchor was unable to be put in.Attempts have been made and additional information on the reported event is unavailable at this time.No adverse events have been reported as a result of the malfunction.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.Visual examination of the returned product identified 4 devices returned, one of which had a fractured prong on the inserter.Dimensional analysis of the product determined that the product, where measured, was conforming to print specifications.Function check was conforming and the devices work as intended.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

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

• Brand Name: JGRKNT 1.0MM MINI 2-0 NDLS
• Type of Device: SPORTSMED, IMPLANTS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9226723
• MDR Text Key: 189619991
• Report Number: 0001825034-2019-04742
• 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: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 02/26/2020

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 Expiration Date: 03/31/2024
• Device Model Number: N/A
• Device Catalogue Number: 912076
• Device Lot Number: 273440
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/27/2019
• Initial Date FDA Received: 10/23/2019
• Supplement Dates Manufacturer Received: 12/19/2019; 02/19/2020
• Supplement Dates FDA Received: 01/14/2020; 02/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1