MAUDE Adverse Event Report: ZIMMER BIOMET, INC. JGRKNT 1.5MM #2 MB SNGL; PROSTHESIS, SPORTSMED

Model Number N/A

Device Problems Migration or Expulsion of Device (1395); Difficult or Delayed Activation (2577)

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

Event Date 06/27/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source: foreign (b)(6).Reported event was unable to be confirmed due to limited information received from the customer.Device history record was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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.

Event Description

It was reported that when surgeon passed juggerknot through sleeves and tried to pull it after hammering, juggerknot came out as it is without firing.No further information is available.

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.Visual examination of the returned product identified the device shows attempted use.The suture is detached from the tip of the device.No damage can be seen to the anchor, suture, or tip of the device.Root cause does not change with the new information.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmerbiomet will continue to monitor for trends.

• Brand Name: JGRKNT 1.5MM #2 MB SNGL
• Type of Device: PROSTHESIS, SPORTSMED
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9385081
• MDR Text Key: 201854229
• Report Number: 0001825034-2019-05394
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• PMA/PMN Number: K150768
• 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: 09/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 912031
• Device Lot Number: P10616
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1