MAUDE Adverse Event Report: ZIMMER BIOMET, INC. AFFIXUS HFN 125 DEG 11MM X 180MM; ROD, FIXATION

Model Number N/A

Device Problems Failure to Advance (2524); Mechanical Jam (2983)

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

Event Date 06/04/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Customer has not yet indicated if the product will 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 is reported that during a hip fracture nailing procedure, the set screw could not be advanced or reversed from its original position.Once it was determined that the nail was malfunctioning, the surgeon requested that another product be opened to complete the procedure.No patient consequences were reported as a result of the malfunction.Attempts have been made and no further information has been provided.

Manufacturer Narrative

Udi -(b)(4).Upon evaluation of the returned product, it is confirmed the set screw is stuck in the nail.No damage was noted on the threads.Dhr was reviewed and no discrepancies were found.A previous investigation determined the root cause to be a manufacturing issue.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.

Event Description

No additional information received.

• Brand Name: AFFIXUS HFN 125 DEG 11MM X 180MM
• Type of Device: ROD, FIXATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7655891
• MDR Text Key: 112996784
• Report Number: 0001825034-2018-04371
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• PMA/PMN Number: PK100238
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 12/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 814311180
• Device Lot Number: 219770
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-3055-2018
• Patient Sequence Number: 1