MAUDE Adverse Event Report: ZIMMER BIOMET, INC. JUGGERSTITCH CURVED IMPLANT; FASTNER, FIXATION

Catalog Number 110024773

Device Problem Malposition of Device (2616)

Patient Problem No Information (3190)

Event Date 10/17/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source: (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 report will be submitted.Product not returned.

Event Description

It was reported that during the surgery, the surgeon noticed that the anchor was installed on the bottom of meniscus when the surgeon applied tension to the suture.The product was removed.No additional patient consequences were reported.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

Upon receipt of additional information, it has been determined no serious injury was reported as a result of this malfunction.Additionally, this malfunction has not previously been reported for having caused a serious injury on a same/similar device in the past.The initial report was forwarded in error and should be voided.

Event Description

Upon receipt of additional information, it has been determined no serious injury was reported as a result of this malfunction.Additionally, this malfunction has not previously been reported for having caused a serious injury on a same/similar device in the past.The initial report was forwarded in error and should be voided.

• Brand Name: JUGGERSTITCH CURVED IMPLANT
• Type of Device: FASTNER, FIXATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9310770
• MDR Text Key: 166784127
• Report Number: 0001825034-2019-05111
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• PMA/PMN Number: K150424
• 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: 02/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 110024773
• Device Lot Number: 415590
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention