MAUDE Adverse Event Report: BIOMET 3I GOLD-TITE HEXED UNISCREW; DENTAL SCREW

Model Number	UNIHG
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/16/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the screw loosened and need to be replaced.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Patient identifier unknown / not provided.Age and date of birth unknown / not provided.Patient sex unknown / not provided.Weight unknown / not provided.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
No additional event information received at the time of this report.
Additional Manufacturer Narrative
This report is being submitted to relay additional information and device evaluation.The following sections are being reported: b4: date of this report was updated.G3: date received by manufacturer was updated.G6: type of report was updated.H2: type of follow up was updated.H3: device evaluated by manufacturer was updated.H6: investigation type codes were added: 3331, 4109, 4110, 4111 and 4114.H6: investigation findings code was added: 213.H6: investigation conclusions codes were added: 4315.H10: narrative/data was updated.One gold-tite hexed uniscrew, unihg was not returned for investigation.Therefore, visual inspection via naked eye and camera magnification could not be performed and the investigation will be of the available information of the item number, risk management files and ifu.Based on the evaluation, 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 events 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 products were within specifications and conforming when they left zimmer biomet.Dhr review was completed for the subject lot number (1254723).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 lot specific complaint history review was performed for the subject lot number 1254723, (complaint category keyword: loosening) for similar events and revealed that there are no existing non-conformances/capa/hhe/d/ie/product holds for the reported product.The reported event could not be recreated due to the nature of the dental device and event (loosening) and the complaint is related to the functional performance of the device.A definitive root cause could not be identified.However, based on the investigation and risk review, the most likely cause for the reported event is inadequate treatment planning, misunderstood or overlooked instructions for use, screw not torqued to specification or improper technique.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.
Additional Manufacturer Narrative
This report is being submitted to relay additional information.
Event or Problem Description
Patient identifier was provided.

• Brand Name: GOLD-TITE HEXED UNISCREW
• Common Device Name: DENTAL SCREW
• 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: 15825707
• Report Number: 0001038806-2022-01794
• Device Sequence Number: 12301322
• Product Code: NHA
• UDI-Device Identifier: 00844868017301
• UDI-Public: (01)00844868017301(17)270614(10)1254723
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K072642
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/28/2022

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: UNIHG
• Device Catalogue Number: UNIHG
• Device Lot Number: 1254723
• 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: 11/16/2022
• Supplement Date Received by Manufacturer: 11/17/2022; 12/21/2022
• Initial Report FDA Received Date: 11/18/2022
• Supplement Report FDA Received Date: 11/28/2022; 12/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2022
• 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: Unknown