MAUDE Adverse Event Report: ZIMMER BIOMET, INC. AFFIXUS HIP FRACTURE NAIL; APPLIANCE, FIXATION

Model Number N/A

Device Problem Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/03/2018

Event Type  malfunction  

Manufacturer Narrative

Zimmer biomet complaint number -(b)(4).(b)(4).Foreign - (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product was used and remains implanted within the patient.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Remains implanted.

Event Description

It was reported during an affixus nail procedure, the set screw would not turn in either direction and would not advance from the original position.The surgeon completed the procedure without using the set screw.No adverse events have been reported as a result of the malfunction.

Event Description

No additional information received.

Manufacturer Narrative

(b)(4).No product was returned; visual and dimensional evaluations could not be performed, reported event was unable to be confirmed.Dhr was reviewed and no discrepancies relevant to the reported event were found.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: AFFIXUS HIP FRACTURE NAIL
• Type of Device: APPLIANCE, FIXATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8033857
• MDR Text Key: 126078518
• Report Number: 0001825034-2018-10212
• Device Sequence Number: 1
• Product Code: JDS
• 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: 02/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 816712165
• Device Lot Number: 826080
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1