MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ANKLE LOCKING NAIL 11 X 150MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	14-440215
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	01/31/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2023-00314.Concomitant medical products: product id was provided for four screws; however, it is unknown which of the four screws fractured.Therefore, the fractured screw could be any of the following: item#: 14-405026; lot#: 461340, item#: 14-405028; lot#: 908590, item#: 14-405046; lot#: 395180, item#: 14-405042; lot#: 775510.Report source: foreign - event occurred in spain.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.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
It was reported that a patient was implanted with the phoenix ankle arthrodesis nail system on an unknown date.Subsequently, after approximately fifteen (15) months of intervention, the patient is still experiencing pain and limited ability to complete activities of daily living.X-rays were provided and reviewed by a healthcare professional.It was noted that there is malposition of the intramedullary rod which extends inferior to the inferior border of the calcaneus into the soft tissues of the foot, and a fractured inferior screw within the calcaneus.It was also noted there is incomplete bony fusion of the tibiotalar joint.Attempts have been made and no further information has been provided.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.H6: proposed annex g component code: mechanical (g04) - im nail.Visual examination of the provided x-rays shows that the screws were broken, and the nail has migrated from its original position.No product was returned as the device remains implanted.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: review of successive radiographs show progressing migration of the nail and fracturing of the screws.Hindfoot fusion with protrusion of the intramedullary rod through the inferior cortex of the calcaneus which worsens with time.Fracture of the inferior most interlocking screw seen within initial imaging with worsening displacement on follow-up imaging.Single ap scout image of the right ankle from a ct scan demonstrates worsening fracture of the inferior-most screw as well as worsening protrusion of the intramedullary rod, poorly evaluated on this study.Two images of the left ankle demonstrate worsening protrusion of the intramedullary rod inferiorly through the calcaneus with more prominent fracture of the inferior most interlocking screw.Review of the device history record(s) identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.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.

• Brand Name: ANKLE LOCKING NAIL 11 X 150MM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 16426954
• Report Number: 0001825034-2023-00374
• Device Sequence Number: 5259564
• Product Code: HSB
• UDI-Device Identifier: 00887868093593
• UDI-Public: (01)00887868093593(17)260208(10)625580
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K091976
• 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,Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/02/2023

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 Expiration Date: 02/08/2026
• Device Catalogue Number: 14-440215
• Device Lot Number: 625580
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/01/2023
• Supplement Date Received by Manufacturer: 07/31/2023
• Initial Report FDA Received Date: 02/23/2023
• Supplement Report FDA Received Date: 08/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/08/2016
• 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: NI
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 50 YR
• Patient Sex: Male