MAUDE Adverse Event Report: BIOMET 3I RIGHT ANGLE SLOTTED DRIVER TIP, 24MM; DENTAL DRIVER

Model Number	RASD1
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).
Event or Problem Description
It was reported that the driver fractured.The doctor confirms that the procedure was completed with other instruments and that the patient did not suffer any negative impact on his health.
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).The following sections have been updated: h3: device evaluated by manufacturer: change ¿no' to 'yes.' one right angle slotted driver tip, 24mm (rasd1) was returned for investigation.Visual inspection of the as returned product identified that the device had fractured at the tip.The reported event could not be recreated due to the nature of the dental devices and event (fracture).Patient conditions, tooth location and duration of placement are irrelevant to this investigation.Device history record (dhr) review was completed for the subject lot number 1227470.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 by lot number (1227470) was performed for similar events using keyword 'functional fracture' and no other similar complaint was identified.September post market trending was reviewed and there were no actionable events or corrective actions for the reported event (fracture) or product.Therefore, based on the available information, device malfunction has occurred for both devices and the reported event was confirmed.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: RIGHT ANGLE SLOTTED DRIVER TIP, 24MM
• Common Device Name: DENTAL DRIVER
• 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: 12292472
• Report Number: 0001038806-2021-01471
• Device Sequence Number: 3181567
• Product Code: NDP
• UDI-Device Identifier: 00844868015215
• UDI-Public: (01)00844868015215(17)290427(10)1227470
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: EXEMPT
• 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
• Report Date (Section B): 11/17/2021

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 Model Number: RASD1
• Device Catalogue Number: RASD1
• Device Lot Number: 1227470
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2021
• 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: 07/16/2021
• Supplement Date Received by Manufacturer: 11/08/2021
• Initial Report FDA Received Date: 08/09/2021
• Supplement Report FDA Received Date: 11/17/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/30/2019
• 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 Sex: Female