MAUDE Adverse Event Report: ZIMMER BIOMET, INC. JUGGERKNOT SOFTAN NADEL RUND 2.9MM; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number N/A

Device Problem Fracture (1260)

Patient Problems Necrosis (1971); Fracture, Arm (2351)

Event Date 02/04/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source: foreign country: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, due to the device was discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported patient was revised approximately 3 months post implantation due to implant fracture.The surgeon stated fracture of the upper arm at the borehole of the juggerknot 2.9mm.The surgeon suspects borehole necrosis through the spade drill of the juggerknot 2.9mm.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of radiographs received.Review of the available records identified minimally displaced fracture of the proximal left humerus.Device history record (dhr) review was unable to be performed as the item and lot number of the device involved in the event is unknown.Root cause of the event could not be determined.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.

• Brand Name: JUGGERKNOT SOFTAN NADEL RUND 2.9MM
• Type of Device: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9782620
• MDR Text Key: 181916099
• Report Number: 0001825034-2020-00987
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• 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: 05/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/17/2020
• Initial Date FDA Received: 03/03/2020
• Supplement Dates Manufacturer Received: 05/21/2020
• Supplement Dates FDA Received: 05/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention