MAUDE Adverse Event Report: BIOMET 3I ANGLED SCREW CHANNEL DRIVER TIP 30MM; DENTAL DRIVER

Model Number	ASCDT30
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).
Event or Problem Description
It was reported that the tip of the fractured during a procedure.Another driver tip was used to complete the procedure.As a result of this event, no injury to the patient was reported.Tooth location not reported.
Additional Manufacturer Narrative
The following sections have been updated: g6: checked "follow-up".
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
An angled screw channel driver tip 30mm (ascdt30) was returned for investigation.Visual inspection of the as returned product identified a fracture at tip.Pre-existing patient factors, x-ray, tooth location are not relevant to the reported event.The length of the device usage is unknown.Pictures or x-ray images were not provided.Appropriate documentation was reviewed.Dhr review was completed for the subject lot number (1234424).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 was performed for the reported lot number (1234424) for similar event and no other complaint was identified.Based on the available information, device malfunction did occur and the reported event was confirmed.The following sections have been updated: b4: date of this report g3: date received by manufacturer g6: checked "follow-up" h2: checked follow-up type h3: changed "no" to "yes" h6: entered evaluation codes h10: added manufacturer narrative.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: ANGLED SCREW CHANNEL 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: 12624571
• Report Number: 0001038806-2021-01954
• Device Sequence Number: 4522146
• Product Code: NDP
• UDI-Device Identifier: 00844868044024
• UDI-Public: (01)00844868044024(17)250127(10)1234424
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/08/2022

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: Health Professional
• Device Expiration Date: 01/27/2025
• Device Model Number: ASCDT30
• Device Catalogue Number: ASCDT30
• Device Lot Number: 1234424
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/06/2021
• Supplement Date Received by Manufacturer: 10/14/2021; 04/07/2022
• Initial Report FDA Received Date: 10/13/2021
• Supplement Report FDA Received Date: 10/21/2021; 04/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/29/2020
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose