MAUDE Adverse Event Report: BIOMET 3I CERTAIN¿ TITANIUM HEXED SCREW; DENTAL SCREW

Model Number IUNIHT

Device Problem Unintended Movement (3026)

Patient Problem Pain (1994)

Event Date 10/26/2022

Event Type  malfunction  

Manufacturer Narrative

Zimmer biomet complaint number (b)(4).

Event Description

The doctor reports that the screws loosen despite having used the manufacturer's recommended torque.The affected tooth position is #16.The doctor reports "pain".

Manufacturer Narrative

Zimmer biomet complaint number (b)(4).The following fields have been updated: b4: date of this report b5: describe event or problem d4: additional device information g3: date received by manufacturer g6: type of report h1: type of reportable event h2: follow up type h3: device evaluated by manufacturer h4: device manufacturer date h6: adverse event problem h10: additional narrative two (2) certain titanium hexed screw (iuniht) were returned for investigation.Visual evaluation of the as returned product identified signs of use, however, no damage was seen.Functional testing was performed with an in-house mating device (implant).The devices were able to engage as normal.No malfunction was identified.Therefore, the reported event could not be recreated.Pre-existing condition noted in the per was low bone density (type iii and type iv).The device had been placed on tooth # 16 (universal).Dhr review was completed for the subject lot number 1248825.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, were noted as part of the dhr.Lot was inspected and passed all acceptance criteria by qa.Complaint history review was performed for the reported lot number 1248825 for similar events and 1 other relevant complaint(s) was identified.Review completed utilizing keywords: functional : loosening.Therefore, based on the available information device malfunction did not occur.Additionally, the reported event could not be verified as the exact details of event were nonverifiable.

Event Description

No further event information is available at the time of this report.

• Brand Name: CERTAIN¿ TITANIUM HEXED SCREW
• Type of Device: 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: 15899442
• MDR Text Key: 307669552
• Report Number: 0001038806-2022-01846
• Device Sequence Number: 1
• Product Code: NHA
• UDI-Device Identifier: 00844868008545
• UDI-Public: (01)00844868008545(17)260916(10)1248825
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K072642
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 03/28/2023

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
• Device Operator: Lay User/Patient
• Device Model Number: IUNIHT
• Device Catalogue Number: IUNIHT
• Device Lot Number: 1248825
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/09/2022
• Initial Date FDA Received: 12/01/2022
• Supplement Dates Manufacturer Received: 03/13/2023
• Supplement Dates FDA Received: 03/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/17/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 39 YR
• Patient Sex: Male