MAUDE Adverse Event Report: BIOMET 3I TITANIUM HEXED UNISCREW; DENTAL SCREW

Model Number	UNIHT
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).
Event or Problem Description
It was reported a screw fractured.Fracture portions were removed.
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4) the following sections have been updated: b4: date of this report b5: describe event or problem d4: lot number d4: expiration date d4: udi g3: date received by manufacturer h1: type of report, follow-up number h2: follow up type h4: device manufacture date h10: additional narrative.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).Two titanium hexed uniscrew, uniht were returned for investigation.Visual inspection via naked eye and camera magnification confirmed that the screws were fractured at the threads.Drive feature showed signs of usage and the hexes were rounded out.Functional testing to recreate the reported event could not be performed due to the nature of the device and event.Per: no pre-existing conditions were noted on the per form.The bone density was ii.The reported devices were located on tooth sites 13 & 14 (fdi) and the length of time used was unknown.Picture/x-rays: pictures or x-ray images were not provided.Review of appropriate documentation: documents reviewed: biomet 3i restorative products ifu (p-iis086gr) rev f - october 2019.Information identified: 'precautions' 'breakage' 'warning' per the applicable ifu, breakage may occur when device is loaded beyond its functional capability.Dhr review: dhr review was completed for the subject lot number (1245142).It was confirmed that all operations and inspections were executed as per applicable procedure.No deviations or non-conformance's, 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: a lot specific complaint history review number was conducted (1245142 ).The review revealed that there are no existing nonconformance's/capa/hhe/d/ie/product holds for the reported device related to the reported event for similar events (complaint category keywords: fracture screw) and no other complaint was identified.Post market trend review: january post market trending was reviewed and there were no negative trends or corrective actions for the reported event (fracture screw) and device (uniht x 2).Malf/event: based on the available information, device malfunction did occur and the reported event was confirmed.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: TITANIUM HEXED 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: 12681558
• Report Number: 0001038806-2021-02043
• Device Sequence Number: 12367295
• Product Code: NHA
• UDI-Device Identifier: 00844868017318
• UDI-Public: (01)00844868017318(17)260426(10)1245142
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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,Followup
• Report Date (Section B): 03/31/2022

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: 04/26/2026
• Device Model Number: UNIHT
• Device Catalogue Number: UNIHT
• Device Lot Number: 1245142
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2021
• 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: 10/01/2021
• Supplement Date Received by Manufacturer: 11/04/2021; 03/30/2022
• Initial Report FDA Received Date: 10/22/2021
• Supplement Report FDA Received Date: 11/17/2021; 03/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/27/2021
• 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: 64 YR
• Patient Sex: Male