MAUDE Adverse Event Report: ZIMMER BIOMET, INC. JUGGERKNOT SINGLE 1.4MM 1 #1 MB; FASTENER, FIXATION

Model Number N/A

Device Problems Difficult or Delayed Positioning (1157); Migration or Expulsion of Device (1395); Appropriate Term/Code Not Available (3191)

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

Event Date 10/16/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source, foreign ¿ events occurred in (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.

Event Description

It was reported that during a meniscal suture repair surgery, the anchor of this product was pulled out from the patient's burr hole.Therefore, the surgeon used an alternative product to complete the surgery.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

Complaint sample was evaluated and the reported event was confirmed.Visual review identified some minor damage to the threads of the anchor, indicating use.Functional testing is not possible as the device was returned disassembled.There are no visual indications that the device should have failed.Device history record (dhr) was reviewed and no discrepancies were found.Review of the complaint history determined that no further action(s) is/are required.Root cause was unable to 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: JUGGERKNOT SINGLE 1.4MM 1 #1 MB
• Type of Device: FASTENER, FIXATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7014580
• MDR Text Key: 92649792
• Report Number: 0001825034-2017-10039
• Device Sequence Number: 1
• Product Code: JDR
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PK071704
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/15/2018

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: Physician
• Device Expiration Date: 06/27/2021
• Device Model Number: N/A
• Device Catalogue Number: 912030
• Device Lot Number: P03927
• Other Device ID Number: SEE H10 NARRATIVE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/17/2017
• Initial Date FDA Received: 11/09/2017
• Supplement Dates Manufacturer Received: 01/15/2018
• Supplement Dates FDA Received: 01/15/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/27/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1