MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ANKLE LOCKING NAIL 10 X 150MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	14-440115
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	05/31/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Foreign - event occurred in the uk.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product location is unknown.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 the patient received a trauma nail on an unknown date.Subsequently, the patient was revised approximately six (6) weeks ago due to a periprosthetic bone fracture.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
The investigation is in process.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 or Problem Description
No further event information available at the time of this report.
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 component code - im nail.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Radiographs were provided and reviewed by a health care professional on linked complaint (b)(4).Review of the available records identified the following: single ap view of the right ankle demonstrates a hind foot fusion with intramedullary rod and one proximal and one distal interlocking screw.Oblique fracture through the distal tibial diaphysis along with a bimalleolar fracture.Linear lucency just proximal to the proximal tip of the tibial intramedullary rod could indicate missed drill hole.Osteopenia.Ankle mortise disruption.Review of the device history record(s) identified no deviations or anomalies during manufacturing.The x-rays indicate a drill hole at the same level as the fracture.The fracture was caused by the drill, not the nail.As the nail was not the reason for the bone fracture, there is no device problem found for this event.The event involving the drill hitting the bone during implantation has already been reported under mdr# 0001825034-2023-02996 and mdr# 0001825034-2023-02997.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 10 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: 17342618
• Report Number: 0001825034-2023-01610
• Device Sequence Number: 17865977
• Product Code: HSB
• UDI-Device Identifier: 00887868093531
• UDI-Public: (01)00887868093531(17)330123(10)162310
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K081243
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/10/2024

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 14-440115
• Device Lot Number: 162310
• 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: 06/22/2023
• Supplement Date Received by Manufacturer: 08/09/2023; 01/09/2024
• Initial Report FDA Received Date: 07/18/2023
• Supplement Report FDA Received Date: 08/16/2023; 01/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/23/2023
• 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: Hospitalization; Required Intervention
• Patient Sex: Prefer Not To Disclose