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

Catalog Number	CSD04
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).A2: patient age is not provided / unknown.A4: patient weight is not provided / unknown.B3: date of event is not provided / unknown.E1: initial reporter¿s title and last name are not provided / unknown.
Event or Problem Description
It was reported that the bar fractured in half on the distal.
Additional Manufacturer Narrative
This report is being submitted to report additional information.Zimvie did not receive the subject for evaluation.Visual inspection could not be performed.The investigation has been performed based on the available information.Dhr review was completed for the subject lot number.It was observed that the bar had been milled 6 years before the event was registered.No deviations or non-conformance's, which could have caused or contributed to the reported event, were noted as part of the dhr.Digital design review revealed that the designed bar matched the drawing.No further design review was needed.A definitive root cause could not be determined.Therefore, based on the available information, a device malfunction could not be verified.Without device receipt, the reported event is non-verifiable.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.Zimvie will continue to monitor for trends.
Event or Problem Description
No additional or corrected information to report.

• Brand Name: BELLATEK¿ DOLDER¿ 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: susanne taylor ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5617766700
• MDR Report Key: 17071291
• Report Number: 0001038806-2023-01080
• Device Sequence Number: 5886386
• Product Code: NHA
• UDI-Device Identifier: 00844868001515
• UDI-Public: (01)00844868001515(10)6865554-1
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/07/2023

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: Other
• Device Catalogue Number: CSD04
• Device Lot Number: 6865554-1
• 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: 05/10/2023
• Supplement Date Received by Manufacturer: 05/10/2023
• Initial Report FDA Received Date: 06/06/2023
• Supplement Report FDA Received Date: 09/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2017
• 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