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

Model Number	UNISG
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).
Event or Problem Description
It was reported that a screw loosened in the patients mouth.It was retightened and will be replaced once they receive replacement.Tooth #17.
Additional Manufacturer Narrative
One gold-tite® square uniscrew (unisg) was returned for investigation.Visual evaluation of the returned product identified some signs of use but no apparent malfunction.However, one unknown implant was not returned.As per information provided by customer, this screw was retightened after this reported event occurred.Functional testing for returned product was performed and no malfunction identified when used with in-house device.Pre-existing conditions as noted on the per was unknown.The devices were located on tooth site #17 (universal) and placed since (b)(6)2021, not removed yet.X-ray or picture images were not provided.Appropriate documentation was reviewed.Dhr review was completed for the subject lot number 1242097.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 (1242097) for similar event and no other complaint was identified.Complaint history and dhr review for unknown implant could not be performed as the item number and lot number was not available.Based on the available information, device malfunction for unisg screw has not occurred and for unknown implant could not be verified and the reported events could not be verified as the exact details of event were non-verifiable and all reported products were not returned.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: GOLD-TITE® SQUARE 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: 12460475
• Report Number: 0001038806-2021-01749
• Device Sequence Number: 4815107
• Product Code: NHA
• UDI-Device Identifier: 00844868017325
• UDI-Public: (01)00844868017325(17)260210(10)1242097
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 02/08/2022

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 Expiration Date: 02/10/2026
• Device Model Number: UNISG
• Device Catalogue Number: UNISG
• Device Lot Number: 1242097
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2021
• 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: 08/24/2021
• Supplement Date Received by Manufacturer: 02/07/2022
• Initial Report FDA Received Date: 09/13/2021
• Supplement Report FDA Received Date: 02/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/11/2021
• 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 Age: 58 YR
• Patient Sex: Male