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

Model Number	UNIHG
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Information (3190)
Date of Event	08/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).
Event or Problem Description
Doctor indicated a loosening of the prosthetic abutment screw with a light rotation of the crown noticed.Doctor removed the screw and placed a new one.Tooth site #46.
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).The following sections have been updated: h3: device evaluated by manufacturer: change ¿no' to 'yes' one certain® gold-tite® hexed screw (iunihg) was returned for investigation.Visual evaluation of the as returned product identified signs of wear and debris on the screw threads and drive feature.No pre-existing conditions were noted on the per.The reported product was located on tooth # 46 and used for an unknown period of time.The reported event could not be recreated due to the nature of the dental device and event (loosening).Dhr review was completed for the subject lot number 114300.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.Complaint history review was performed for the reported lot number (114300) for similar event and no other complaint was identified.September post market trending was reviewed and there were no actionable events or corrective actions for the reported event (components loosening) or product (iunihg).Therefore, based on the available information, device malfunction has not occurred and the reported event was non-verifiable.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: CERTAIN GOLD-TITE HEXED SCREW
• Common Device Name: DENTAL SCREW
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 10592016
• Report Number: 0001038806-2020-01454
• Device Sequence Number: 1152128
• Product Code: NHA
• UDI-Device Identifier: 00844868017301
• UDI-Public: (01)00844868017301(17)051228(10)114300(241)UNIHG
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K072642
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2020

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 Expiration Date: 12/28/2005
• Device Model Number: UNIHG
• Device Catalogue Number: IUNIHG
• Device Lot Number: 114300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/03/2020
• Supplement Date Received by Manufacturer: 11/12/2020
• Initial Report FDA Received Date: 09/28/2020
• Supplement Report FDA Received Date: 12/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 46 YR