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

Catalog Number IUNIHG

Device Problem Unintended Movement (3026)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  malfunction  

Manufacturer Narrative

Zimmer biomet complaint number (b)(4).Date of event: approximately 2 weeks ago.Concomitant medical product: nint411 lot# unknown.Therapy date: approximately 2 weeks ago.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 Description

It was reported that the doctor has a patient that noticed their dental screw had loosened in site #13.The patient came in and the doctor tightened the screw in the meantime but is requesting a new screw to replace the old one.Patient was not injured.

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.D9: device availability and return date 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: 4109, 4110 and 4111.H6: investigation findings code was added: 213.H6: investigation conclusions codes were added: 67 and 4315.H10: narrative/data was updated.One certain® gold-tite® hexed screw (iunihg) was returned for investigation.Visual evaluation of the as returned product identified signs of wear but no apparent signs of malfunction.Functional testing was performed using an applicable in-house mating device.The devices were able to assemble as normal.No pre-existing conditions were noted on the per.The device had been placed on tooth #13 for an unknown period of time.Per the applicable ifu, under section precautions, it is stated that improper technique could cause screw loosening.Also, according to the ifu, patient factors like presence of occlusal abnormalities or parafunctional habits (e.G.Severe bruxism, clenching, overloading, or gnawing) may cause screw loosening, restoration fracture, and/or implant failure.Dhr review could not be performed since the lot number associated to the item was not provided.However, zimmer biomet quality management system (qms) has controls in place to ensure the distribution of conforming product.A complaint history review by item number was conducted for the iunihg dating back to 12 months from now.The complaint history review revealed that there are no existing non-conformances/capa/hhe/d/ie/product holds for the reported product for similar events (complaint category keyword: functional: loosening).August post market trending was reviewed and there were no actionable events or corrective actions for the reported event or product.Therefore, based on the available information, device malfunction did not occur.However, the reported event could not be verified as the exact details of event were non-verifiable.

Event Description

No additional event information received at the time of this report.

• Brand Name: CERTAIN GOLD-TITE HEXED SCREW
• Type of Device: DENTAL SCREW
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 11964509
• MDR Text Key: 255958424
• Report Number: 0001038806-2021-00960
• Device Sequence Number: 1
• Product Code: NHA
• Combination Product (y/n): N
• PMA/PMN Number: K072642
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: IUNIHG
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: D10, MEDICAL PRODUCT: SEE H10 NARRATIVE
• Patient Age: 60 YR