MAUDE Adverse Event Report: BIOMET 3I BELLATEK¿ HYBRID BAR 5 IMPLANTS; DENTAL BAR

Model Number	CSHY05
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
(b)(4).Patient age or date of birth: patient age is not provided / unknown.Weight: patient weight is not provided / unknown.Date of event: date of event is not provided / unknown.Initial reporter name and address: initial reporter¿s title is not provided / unknown.
Event or Problem Description
It was reported that the dental bar fractured.
Additional Manufacturer Narrative
This report is being submitted to report additional information.The following sections are being reported: d4: expiration date is not provided / unknown.D4: unique identifier (udi) number h2: if follow-up, what type h3: device evaluated by manufacturer h4: device manufacturer date h6: health effect - clinical code h6: device code(s) h6: type of investigation h6: investigation findings h6: investigation conclusions h10: additional narratives/data the product was returned and the reported event (fracture) was confirmed following inspection and evaluation of the returned product.Based on the evaluation, the device malfunction did occur.However, 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.Zimvie quality management system (qms) has controls in place to ensure the distribution of conforming product.Therefore, based on the available information, the products were likely within specifications and conforming when they left zimmer biomet.Dhr review was completed for the subject lot number (8696220-1).It was confirmed that all operations and inspections were executed as per applicable procedure.No deviations or non-conformances, which could have caused or contributed to the reported event was noted as part of the dhr.Lot was inspected and passed all acceptance criteria by qa.A definitive root cause could not be determined.No further investigation or immediate capa/hhe/d escalation is required, as the complaint investigation could 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.Zimvie will continue to monitor for trends.
Event or Problem Description
No additional or corrected information to report.

• Brand Name: BELLATEK¿ HYBRID BAR 5 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: 15675324
• Report Number: 0001038806-2022-01635
• Device Sequence Number: 6321099
• Product Code: NHA
• UDI-Device Identifier: 00844868001683
• UDI-Public: (01)00844868001683(17)320124(10)8696220-1
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/22/2023

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: Lay User/Patient
• Device Model Number: CSHY05
• Device Catalogue Number: CSHY05
• Device Lot Number: 8696220-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2022
• 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: 10/04/2022
• Supplement Date Received by Manufacturer: 02/21/2023
• Initial Report FDA Received Date: 10/26/2022
• Supplement Report FDA Received Date: 02/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/26/2022
• 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