MAUDE Adverse Event Report: BIOMET 3I BELLATEK HYBRID BAR 4 IMPLANTS; DENTAL BAR

Catalog Number	CSHY04
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).A2: age and date of birth unknown / not provided.A3: gender unknown / not provided.A4: patient weight unknown / not provided.E1: last name unknown / not provided.G4: additional pma/510(k) number k241032.
Event or Problem Description
It was reported that the free-end saddle of the bar broke off at site # 28-29 area.Lab will be sending back as well as having bar remade.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
Zimvie did not receive one (1) cshy04, (bellatek® hybrid bar 4 implants) for evaluation.Visual evaluation was performed on images received.A small fracture can be observed in the returned prosthesis.Dhr review was completed for the subject lot number 8731083-1.No deviations or non-conformances, which could have caused or contributed to the reported event, were noted as part of the dhr.A lot specific complaint history review is not conducted for psp complaints.Patient specific products have a unique one time use lot number.Therefore, a lot specific history search for the abutment was not performed.The customer did not submit images for the reported event.Digital design file was not needed for this case.Based on the investigation and risk management file review as per project 1166 rev 2, the most likely root cause determined from the investigation was patient factors.Therefore, based on the available information, a device malfunction has occurred.The returned bar was observed to be fractured.The reported event has been confirmed.No further investigation or immediate capa / hhe/d escalation is required, as the complaint investigation did not confirm the products were nonconforming at the time of distribution, and no new failure mode, harm, or hazardous situation was identified through the investigation performed.At this time, the complaint investigation has been completed and the record will be closed.If additional information is received, the record will be re-opened for further evaluation.The following sections have been updated: b4: date of this report g3: date received by manufacturer g6: checked "follow-up" h2: checked follow-up type h3: changed "no" to "yes" h6: entered evaluation codes h10: added manufacturer narrative.

• Brand Name: BELLATEK HYBRID BAR 4 IMPLANTS
• Common Device Name: DENTAL BAR
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: carlos gordian-arroyo ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5619713230
• MDR Report Key: 21079906
• Report Number: 0001038806-2025-00030
• Device Sequence Number: 8333764
• Product Code: NHA
• UDI-Device Identifier: 00844868001676
• UDI-Public: (01)00844868001676(17)320531(10)8731083-1
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K080864
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2025

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: Lay User/Patient
• Device Catalogue Number: CSHY04
• Device Lot Number: 8731083-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/06/2025
• Supplement Report FDA Received Date: 03/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/02/2022
• 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
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic