MAUDE Adverse Event Report: ZIMMER BIOMET, INC. JUGGERKNOT SHORT 1 #1 MAXBRAID- BLUE/WHITE WITH NEEDLES; FASTENER, FIXATION

Model Number N/A

Device Problem Misassembled (1398)

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

Event Date 10/16/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation.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 the surgery, the anchor of the product was not set on the tip of needle when it was opened.The surgeon attempted to align it to the proper position but was unsuccessful.An alternative product was used to complete the surgery.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Dhr was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required.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.

• Brand Name: JUGGERKNOT SHORT 1 #1 MAXBRAID- BLUE/WHITE WITH NEEDLES
• 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: 7042268
• MDR Text Key: 93073391
• Report Number: 0001825034-2017-10404
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PK110145
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 08/16/2022
• Device Model Number: N/A
• Device Catalogue Number: 912068
• Device Lot Number: 776640
• Other Device ID Number: SEE H10 NARRATIVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/16/2017
• 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