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

Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).
Event or Problem Description
Doctor reported screw fracture, need to remove and place a new one.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).The following fields have been updated: b4: date of this report.B5: describe event or problem.D4: additional device information.D9: device availability.G3: date received by manufacturer.G6: type of report.H1: type of reportable event.H2: follow up type.H3: device evaluated by manufacturer.H4: device manufacturer date.H6: adverse event problem.H10: additional narrative.One titanium hexed uniscrew, (uniht) was reported but not returned for investigation.Therefore, visual evaluation could not be performed.Dhr review was completed for the subject lot number 1251182.No deviations or non-conformances, which could have caused or contributed to the reported event, were noted as part of the dhr.Complaint history review was performed for the reported lot number 1251182 for similar events and no other complaints were identified.Review completed utilizing keywords: ¿dental: fracture: screw.¿ based on the investigation, ifu, and risk management file review, the most likely root cause determined from the investigation was customer error (excessive torque applied) or patient factors.Therefore, based on the available information, device malfunction and the reported event could not be verified.
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 33410
• Manufacturer (Section G): BIOMET 3I; 4555 riverside drive; palm beach gardens 33410
• Manufacturer Contact: susanne taylor ; 4555 riverside drive; palm beach gardens 33410 ; 5617766700
• MDR Report Key: 17639820
• Report Number: 0001038806-2023-01653
• Device Sequence Number: 14512130
• Product Code: NHA
• UDI-Device Identifier: 00844868017318
• UDI-Public: (01)00844868017318(17)261215(10)1251182
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2023
• 2 Devices were Involved in the Event: 1 2

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/29/2023
• Supplement Report FDA Received Date: 09/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/15/2021
• 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): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 46 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic