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	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Additional pma/510(k) number: k072642.
Event or Problem Description
It was reported by a cs rep that the ilrghg screw fractured in the patient's mouth.Dr said the patient was not injured and does not know what caused the fracture other than that it is in the smallest implant in a bridge.Dr was able to retrieve the screw and can send back the broken pieces.Tooth #10.
Event or Problem Description
No additional event information at the time of this report.
Additional Manufacturer Narrative
This report is being submitted to relay device evaluation results and additional information.The following sections are being reported: b4: date of this report was updated.D10: unk 3i certain 3.25 implant-lot# unknown g4: date received by manufacturer was updated.G7: type of report was updated.H2: type of follow up was updated.H3: device evaluated by manufacturer was updated.H6: method code was added: 3331, 4109 and 4110.H6: results code was added: 3252.H6: conclusions code was added: 4307.H10: narrative/data was updated.One certain® gold-tite® large hexed screw (ilrghg) was returned for investigation.Visual evaluation of the as returned product identified that it was fractured at the middle threads.A previous complaint for similar fracture occurred.Additionally, an unk 3i implant has been added to the associated item since no allegation was made to it and no further investigation will be performed.Functional testing could not be performed since the device was fractured.Pre-existing conditions and duration of device placed were unknown due to limited information provided by customer.However, device was placed on tooth site #10 (universal).Per the applicable ifu, it is stated that improper technique can lead to device failure.Additionally, breakage may occur when device is loaded beyond its functional capability.Dhr review was completed for the subject lot number 1196425.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.A complaint history review for the subject lot number 1196425 was completed by searching keyword fracture screw in the category through complaint history review and no other similar complaints identified.April post market trending was reviewed and there were no actionable events or corrective actions for the reported event (functional: fracture: screw) or product (ilrghg).Therefore, based on the available information, device malfunction did occur and the reported event was confirmed.

• 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: 11582473
• Report Number: 0001038806-2021-00513
• Device Sequence Number: 2956015
• Product Code: DZE
• UDI-Device Identifier: 00844868006121
• UDI-Public: (01)00844868006121(17)210429(10)1196425
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K972444
• 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): 06/29/2021

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: Health Professional
• Device Expiration Date: 04/29/2022
• Device Model Number: ILRGHG
• Device Catalogue Number: ILRGHG
• Device Lot Number: 1196425
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/16/2021
• Supplement Date Received by Manufacturer: 06/23/2021
• Initial Report FDA Received Date: 03/29/2021
• Supplement Report FDA Received Date: 06/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DENTAL IMPLANT-SEE H10 NARRATIVE
• Patient Age: 75 YR