MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNK CANCELLOUS SCREW; PLATE, FIXATION, BONE

Device Problem Fracture (1260)

Patient Problems Foreign Body In Patient (2687); Insufficient Information (4580)

Event Date 01/13/2011

Event Type  Injury  

Manufacturer Narrative

(b)(4).G2: foreign: italy.It is unknown if product will be returning to zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up report will be submitted.H3 other text : device not returned.

Event Description

It was reported that the screw fractured during the plate removal.No additional patient consequences were reported.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This event is for the screw fracture and implant/explant dates are not needed.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

It was reported a patient experienced a tibia and fibula fracture and underwent a reduction and fixation.Subsequently, during the removal of the fibula plate and screws, one of the screws fractured and the peripheral portion remained within the bone.The procedure was completed without further complications.

• Brand Name: UNK CANCELLOUS SCREW
• Type of Device: PLATE, FIXATION, BONE
• 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: 18641694
• MDR Text Key: 334562970
• Report Number: 0001825034-2024-00254
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/20/2024

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?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/22/2024
• Initial Date FDA Received: 02/05/2024
• Supplement Dates Manufacturer Received: 02/22/2024
• Supplement Dates FDA Received: 03/20/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: COMPRESSION PLATE CAT: 00494500800; UNKNOWN SCREW QTY 7
• Patient Outcome(s): Other
• Patient Age: 44 YR
• Patient Sex: Male