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

Model Number	ILRGHG
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet (b)(4).Patient identifier unknown / not provided.Age and date of birth unknown / not provided.Patient sex unknown / not provided.Weight unknown / not provided.Date of event unknown / not provided.Pma/510(k) number: k072642.
Event or Problem Description
It was reported screw fractured.
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).The following sections have been updated: g7: type of report, follow-up number.H3: device evaluated by manufacturer: change ¿no' to 'yes'.A certain® gold-tite® large hexed screw (ilrghg) was not returned.Since product has not been returned, visual/functional evaluation could not be performed.The investigation has been performed based on the available information.Functional testing to recreate the reported event could not be performed due to the nature of the device and event.No pre-existing conditions were noted on the complaint.The reported device was located and length of use is unknown.Pictures or x-ray images were not provided.Dhr review was completed for the subject lot number (1203736).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 (lot) for similar event and no other complaint was identified.August post market trending was reviewed and there were no actionable events or corrective actions for the reported event or device.Based on the available information, device malfunction could not be verified 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 LARGE HEXED SCREW
• Common Device Name: DENTAL SCREW
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 10395182
• Report Number: 0001038806-2020-01125
• Device Sequence Number: 2605610
• Product Code: DZE
• UDI-Device Identifier: 00844868006121
• UDI-Public: (01)00844868006121(17)220112(10)1203736(241)ILRGHG
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K972444
• 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): 10/19/2020

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: Health Professional
• Device Expiration Date: 01/12/2022
• Device Model Number: ILRGHG
• Device Catalogue Number: ILRGHG
• Device Lot Number: 1203736
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/24/2020
• Supplement Date Received by Manufacturer: 10/14/2020
• Initial Report FDA Received Date: 08/12/2020
• Supplement Report FDA Received Date: 10/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1