MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TI-DBLE LEAD CORT 5.0X80MM SCR; FIXATION, FASTENER

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Medical product: catalog #: 14-440221, ankle locking nail 11 x 210mm x 210mm, lot # 244390, catalog #: 14-405022, ti-dble lead cort 5.0x22mm scr ia5.0x22mm, lot # 112150 qty 2, catalog #: 14-444180, offset end cap 12x0mm ffset, lot # 148830.Report source: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2021-01992.
Event or Problem Description
It was reported a posterior/anterior cortical screw was inserted into the ankle phoenix nail to a patient with charcot deformity.During follow up checkups in clinic, it was discovered that the screw broke months after surgery.X-ray images received noted lucency along the nail.Attempts have been made and there is no further information at this time.
Additional Manufacturer Narrative
(b)(4).Reported event was confirmed as the radiographs provided showed that a calcaneal surgical screw within a phoenix nail device is fractured with slight displacement and angulation of the screw tip.There is extensive lucency along the inferior aspect of the nail.This portion of the nail is loose and there is nonunion.There is a charcot foot deformity but alignment in the lateral view is maintained.The bones are osteopenic.Calcaneal screw fracture in the setting of a phoenix nail device in the setting of a charcot foot.The inferior aspect of the phoenix nail is loose secondary to the screw fracture.The screw is fractured, but no contributing factors are identified.Device history record was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause could not 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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: TI-DBLE LEAD CORT 5.0X80MM SCR
• Common Device Name: FIXATION, FASTENER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 12214374
• Report Number: 0001825034-2021-02143
• Device Sequence Number: 16939011
• Product Code: HSB
• UDI-Device Identifier: 00887868092732
• UDI-Public: (01)00887868092732(17)290828(10)438140
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K063570
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 14-405080
• Device Lot Number: 438140
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2021
• Supplement Date Received by Manufacturer: 11/04/2021
• Initial Report FDA Received Date: 07/22/2021
• Supplement Report FDA Received Date: 11/09/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/28/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Patient Sex: Unknown