MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ANKLE LOCKING NAIL 11 X 210MM X 210MM; PROSTHESIS, TRAUMA

Catalog Number 14-440221

Device Problems Detachment of Device or Device Component (2907); Material Integrity Problem (2978)

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

Event Date 01/27/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source foreign - event occurred in (b)(6).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-00919.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.If any further information 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

It was reported that an operation was performed with a phoenix ankle nail.During the procedure, the connecting portion between the nail and bolt had come off when the surgeon inserted the nail into the patient.The surgeon removed the nail and tried to connect the nail with the bolt; however, it couldn't reconnect.Surgeon then used a backup nail to finish the operation.

Manufacturer Narrative

Complaint sample was evaluated and the reported event was confirmed.Visual examination of the returned product identified that the threads on both bolt and nail are stripped.The bolt has a potential field age of 8 years.The device history record (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 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: ANKLE LOCKING NAIL 11 X 210MM X 210MM
• Type of Device: PROSTHESIS, TRAUMA
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9774666
• MDR Text Key: 198120095
• Report Number: 0001825034-2020-00918
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 00887868093616
• UDI-Public: (01)00887868093616
• Combination Product (y/n): N
• PMA/PMN Number: K081243
• 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: 06/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 14-440221
• Device Lot Number: 244390
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: CONNECTING BOLT CATALOG#: 14-440042 LOT#: PT24A.