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

Catalog Number	CSHY04
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimvie complaint (b)(4).
Event or Problem Description
It was reported that the bar broke in the cylinder #21 area.Tooth- 21, 23, 25/26,28/29.
Additional Manufacturer Narrative
This report is being submitted to report additional information.Zimvie received one bar for evaluation.Visual inspection confirmed the bar was fractured through the cylinder at site #21.Dhr review was completed for the subject lot number.The bar was milled in 2016.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 this complaint is not performed.Based on the investigation and risk management file review, the most likely root cause determined from the investigation was excessive occlusal forces.Therefore, based on the available information, a device malfunction did occur.The reported event is confirmed following inspection and investigation.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.
Event or Problem Description
No additional or corrected information to report.

• Common Device Name: BELLATEK¿ HYBRID BAR 4 IMPLANTS
• 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: 18768214
• Report Number: 0001038806-2024-00297
• Device Sequence Number: 17287828
• Product Code: NHA
• UDI-Device Identifier: 00844868001676
• UDI-Public: (01)00844868001676(10)8258575-1
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 07/22/2024

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: 8258575-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 02/23/2024
• Supplement Report FDA Received Date: 07/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/13/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic