MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ANKLE LOCKING NAIL 11 X 210MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	06/19/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Year of implantation: 2018.Foreign country: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, device was returned to the patient.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported patient was implanted with a phoenix arthrode nail as part of an ankle arthrodesis on unknown date.During a post operation checkup, it was found that the nail in the lower area was fractured.Subsequently, the device was removed approximately two years post implantation.It was decided to remove it completely and have it healed without a replacement implant.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
Reported event was confirmed by review of photographs received.Visual examination of the provided pictures identified one ankle locking nail is fractured.The arthrode nail and both locking nails show nicks and wear that are typical with implant use.Radiographs were provided and reviewed by a health care professional.Review of the available records identified fracture of the distal aspect of the fixation nail as noted on limited fluoroscopic images.Poor image quality does not allow assessment of the implant fit or alignment and bone quality cannot be assessed.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 or Problem Description
No further event information available at the time of this report.

• Brand Name: ANKLE LOCKING NAIL 11 X 210MM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10239872
• Report Number: 0001825034-2020-02647
• Device Sequence Number: 3574261
• Product Code: HSB
• UDI-Device Identifier: 00887868093616
• UDI-Public: (01)00887868093616
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K091976
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2020

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
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 14-440221
• Device Lot Number: 507630
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/29/2020
• Supplement Date Received by Manufacturer: 10/14/2020
• Initial Report FDA Received Date: 07/07/2020
• Supplement Report FDA Received Date: 10/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention