MAUDE Adverse Event Report: BIOMET 3I NARROW RIGHT ANGLE LARGE HEX DRIVER TIP 24MM; DENTAL INSTRUMENT

Model Number	RASH3N
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).
Event or Problem Description
It was reported that the screwdriver fractured while screwing the abutment into the mouth.No other tools were damaged., the screw was not fractured, another screwdriver was used to place the abutment.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).One (1) narrow right angle large hex driver tip 24mm (rash3n) was returned for investigation.Visual evaluation of the as returned implant identified that the driver fractured.Functional testing to recreate the reported event could not be performed due to the nature of the device & event.Pre-existing patient factors, x-ray, and tooth location are not relevant to the reported event.Additionally, the customer did not provide images.The length of the driver's usage is unknown.Device history record (dhr) review was completed for the subject lot number (1226419).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, were noted as part of the dhr.Lot was inspected and passed all acceptance criteria by qa.Complaint history review was performed for the reported lot number for similar events and no other complaint was identified.Review completed utilizing keywords: fracture.Therefore, based on the available information, device malfunction did occur, and the reported event of fracture was confirmed.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: NARROW RIGHT ANGLE LARGE HEX DRIVER TIP 24MM
• Common Device Name: DENTAL INSTRUMENT
• 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: 15436291
• Report Number: 0001038806-2022-01453
• Device Sequence Number: 6006111
• Product Code: NDP
• UDI-Device Identifier: 00844868015260
• UDI-Public: (01)00844868015260(17)240504(10)1226419
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2023

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: 05/04/2024
• Device Model Number: RASH3N
• Device Catalogue Number: RASH3N
• Device Lot Number: 1226419
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2022
• 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: 08/26/2022
• Supplement Date Received by Manufacturer: 01/11/2023
• Initial Report FDA Received Date: 09/16/2022
• Supplement Report FDA Received Date: 01/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/06/2019
• Is the Device Labeled for Single Use? (Y/N): No
• 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: Unknown