MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TIBIAL NAIL YELLOW 9.3MM DIAMETER 34CM LENGTH; ROD, FIXATION/TRAUMA

Model Number N/A

Device Problem Fracture (1260)

Patient Problem Failure of Implant (1924)

Event Date 08/31/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: item#: 47-2484-030-50, z nail 5.0x30 cort screw fa; lot#: 64869036.Item#: 47-2484-030-50, z nail 5.0x30 cort screw fa; lot#: 64875696.Item#: 47-2484-027-50, z nail 5.0x27.5 cort screw fa; lot#: 64283166.Item#: 47-2484-042-50, z nail 5.0x42.5 cort screw fa; lot#: 65023623.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.

Event Description

It was reported that the patient had an initial right lower leg surgery when the implant was implanted.Subsequently, approximately six (6) weeks later during a follow up appointment, it was noticed on x-ray that the implant was fractured.The patient was revised approximately two (2) weeks later to explant the implant and replace it with a larger implant.

Manufacturer Narrative

(b)(4).Visual examination of the returned product identified approximately 1 inch of the distal end is fractured.The fracture runs through a screw hole.Damage in the form of scratches or gouges are seen on the fractured piece.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: significant findings include acute angulation of the distal tibial intramedullary rod suggesting hardware fracture with possible lucency noted anteriorly in this region.A definitive root cause cannot 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 Description

No further event information available at the time of this report.

• Brand Name: TIBIAL NAIL YELLOW 9.3MM DIAMETER 34CM LENGTH
• Type of Device: ROD, FIXATION/TRAUMA
• 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: 12514948
• MDR Text Key: 272773720
• Report Number: 0001822565-2021-02731
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082770
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/04/2022

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 47249534009
• Device Lot Number: 64941866
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/31/2021
• Initial Date FDA Received: 09/22/2021
• Supplement Dates Manufacturer Received: 12/16/2021
• Supplement Dates FDA Received: 01/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/15/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 68 YR
• Patient Sex: Intersex
• Patient Weight: 90 KG