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)
Date of Event	02/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet (b)(4).Weight unknown / not provided.Pma/510(k) number: k072642.
Event or Problem Description
It was reported that the screw fractured.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Although the manufacturer (zb eu authorized representative) has received the product (ilrghg) the manufacturing/investigation site has not received/evaluated the actual devices due to covid protocols and delays in shipment (lost in transit by ups, tracking (b)(4).Therefore, the products has not been physically inspected.The investigation was performed using applicable instructions for use and risk files.Functional testing could not be performed as the product has not been physically inspected.No pre-existing conditions were noted on the per.The event occurred at tooth site 14 (fdi).The implant had been placed for approximately 1 year.X-ray and picture images were not provided.Dhr review for the lot (1192745 ) had revealed no deviations nor non-conformances which could have caused or contributed to the reported event.Product was 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 lot (1192745) for similar event and no other complaint about nonconforming products was identified.September post market trending was reviewed and there were no actionable trends or corrective actions for the reported devices and events.Therefore, based on the available information, device malfunction could not be verified.Additionally, the reported event could not be verified as the product has not been physically inspected.
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: 10367582
• Report Number: 0001038806-2020-01075
• Device Sequence Number: 16381493
• Product Code: DZE
• UDI-Device Identifier: 00844868006121
• UDI-Public: (01)00844868006121(17)210126(10)1192745(241)ILRGHG
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• 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): 11/30/2020

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: 01/26/2021
• Device Model Number: ILRGHG
• Device Catalogue Number: ILRGHG
• Device Lot Number: 1192745
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/15/2020
• Supplement Date Received by Manufacturer: 11/24/2020
• Initial Report FDA Received Date: 08/05/2020
• Supplement Report FDA Received Date: 11/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 77 YR