MAUDE Adverse Event Report: BIOMET 3I RIGHT ANGLE SLOTTED DRIVER TIP 30MM; 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.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).The following sections have been updated: b4: date of this report.B5: describe event or problem.D1: brand name.D2: device product code.D4: catalog.G3: date received by manufacturer.H1: type of report, follow-up number.H2: follow up type.H10: additional narrative.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
Zimmer biomet (b)(4).One right angle slotted driver tip 30mm (rasd6) 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 could not be performed for item rasd6, as the lot number associated with the reported product is not available.Complaint history review by item (rasd6) was performed over a one-year period.And no complaints related to nonconforming products were identified, using keyword 'fracture'.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.

• Brand Name: RIGHT ANGLE SLOTTED DRIVER TIP 30MM
• 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: 12292462
• Report Number: 0001038806-2021-01470
• Device Sequence Number: 3181566
• 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,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: RASD6
• Device Lot Number: 1227470
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/16/2021
• Supplement Date Received by Manufacturer: 08/24/2021; 11/08/2021
• Initial Report FDA Received Date: 08/09/2021
• Supplement Report FDA Received Date: 09/21/2021; 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