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

Model Number	CS275
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Information (3190)
Date of Event	09/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Weight unknown/not provided.
Event or Problem Description
It was reported that the screw placed at tooth site 3 fractured and was completely removed.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).A gold-tite® square uniscrew screw (unisg) was returned for investigation.Visual inspection of the as returned product identified worn markings due to usage and a fracture at the treads.Device history record (dhr) review was completed for the subject lot number (1177270).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 (1177270) for similar event and no other complaint was identified.Based on the available information, device malfunction did occur and the reported event was confirmed.

• Brand Name: GOLD-TITE SQUARE UNISCREW
• Common Device Name: DENTAL SCREW
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 10883779
• Report Number: 0001038806-2020-01878
• Device Sequence Number: 3254176
• Product Code: NHA
• UDI-Device Identifier: 00844868001386
• UDI-Public: (01)00844868001386(17)121011(10)746685(241)CS275
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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): 02/26/2021

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: 10/09/2019
• Device Model Number: CS275
• Device Catalogue Number: UNISG
• Device Lot Number: 1177270
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/30/2020
• Supplement Date Received by Manufacturer: 02/19/2021
• Initial Report FDA Received Date: 11/23/2020
• Supplement Report FDA Received Date: 02/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 45 YR