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	10/19/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Doctor reported loosening of screw.Patient has been rescheduled for new screw placement.Placed on (b)(6) 2019 and removed on (b)(6) 2021.
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).Weight unknown / not provided.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).One gold-tite® square uniscrew (unisg) was returned for investigation.Visual evaluation of the as returned screw identified signs of use but no apparent signs of malfunction.Functional testing was performed with an in-house mating device.The devices were able to engage as normal.No malfunction was identified.Device history record (dhr) review for the lot (1224846) had revealed no deviations nor non-conformances which could have caused or contributed to the reported event.All products were conforming at the time they left zimmer biomet.Lot was inspected and passed all acceptance criteria by qa.Complaint history review was performed for the reported lot number (1224846) for similar events (complaint category keywords: loosening) and no other complaint was identified.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 nonverifiable.
Event or Problem Description
No further event information is 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: 13117237
• Report Number: 0001038806-2021-02428
• Device Sequence Number: 4518075
• Product Code: NHA
• UDI-Device Identifier: 00844868017325
• UDI-Public: (01)00844868017325(17)240304(10)1224846
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2022

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: 03/04/2024
• Device Model Number: UNISG
• Device Catalogue Number: UNISG
• Device Lot Number: 1224846
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2021
• 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: 12/16/2021
• Supplement Date Received by Manufacturer: 04/12/2022
• Initial Report FDA Received Date: 12/30/2021
• Supplement Report FDA Received Date: 04/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/06/2019
• 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: Unknown
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Sex: Male