MAUDE Adverse Event Report: BIOMET 3I BELLATEK® HYBRID BAR 6 IMPLANTS; DENTAL BAR

Model Number	CSHY06
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
Zimmer biomet complaint (b)(4).
Event or Problem Description
It was reported that the bar fractured.The location of the fracture is unknown.
Additional Manufacturer Narrative
This report is being submitted to report additional information.The following sections are being reported: d4: unique identifier (udi) number h2: if follow-up, what type h3: device evaluated by manufacturer h4: device manufacturer date h6: type of investigation h6: investigation findings h6: investigation conclusions h10: additional narratives/data the product was not returned and the reported event could not be verified, as the exact details of device usage and the patient¿s anatomical conditions were unknown.Also, no x-rays were provided for the reported event.Based on the evaluation, the device malfunction could not be verified.Additionally, there is no existing nonconformance/capa/hhe/d/ie/product holds against the reported devices that could cause or contribute to the reported event.Monthly post market trending review identified no adverse trends or corrective actions for the reported event or device.Zimmer biomet quality management system (qms) has controls in place to ensure the distribution of conforming product.Therefore, based on the available information, the product was likely within specifications and conforming when it left zimmer biomet.The reported event could not be recreated due to the nature of the dental device and event and the complaint is related to the functional performance of the device.A definitive root cause could not be determined.No further investigation or immediate capa/hhe/d escalation is required, as the complaint investigation did not confirm the product was nonconforming at the time of distribution, and no new failure mode, harm, or hazardous situation was identified through the investigation performed.If any further information is found 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 additional or corrected information to report.

• Brand Name: BELLATEK® HYBRID BAR 6 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: susanne taylor ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5617766700
• MDR Report Key: 13040047
• Report Number: 0001038806-2021-02402
• Device Sequence Number: 5409817
• Product Code: NHA
• UDI-Device Identifier: 00844868001690
• UDI-Public: (01)00844868001690(10)1215439
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: K080864
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2022

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 Model Number: CSHY06
• Device Catalogue Number: CSHY06
• Device Lot Number: 1215439
• 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: 12/01/2021
• Supplement Date Received by Manufacturer: 06/08/2022
• Initial Report FDA Received Date: 12/18/2021
• Supplement Report FDA Received Date: 06/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose