MAUDE Adverse Event Report: BIOMET 3I TSV ANGLED SCREW CHANNEL DRIVER 24MM; DENTAL DRIVER

Catalog Number	TASCD24
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).A4: patient weight: unknown / not provided.
Event or Problem Description
The screwdriver fractured at the tip on the first tightening turn when fitting the crown.Procedure not completed.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).Zimvie received one (1) tascd24, (tsv angled screw channel driver 24mm) for evaluation.Visual evaluation was performed, the drivers tip was fractured at the tip.The fractured piece was not returned.Dhr review was completed for the subject lot number 1282247.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 1282247 for similar events and 1 other relevant complaint(s) was identified.Review completed utilizing keywords: dental : functional : fracture.Based on the investigation and risk management file review, the most likely root cause determined from the investigation was customer error.Therefore, based on the available information, a device malfunction did occur.The driver¿s tip was fractured.The fractured piece was not returned.The reported event was confirmed.No further investigation or immediate capa / hhe/d escalation is required, as the complaint investigation did not confirm the products were nonconforming at the time of distribution, and no new failure mode, harm, or hazardous situation was identified through the investigation performed.

• Brand Name: TSV ANGLED SCREW CHANNEL DRIVER 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: carlos gordian-arroyo ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5619713230
• MDR Report Key: 20734844
• Report Number: 0001038806-2024-02705
• Device Sequence Number: 21021659
• Product Code: NDP
• UDI-Device Identifier: 00844868044741
• UDI-Public: (01)00844868044741(11)240723(10)1282247
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: EXEMPT
• 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: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2025

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 Catalogue Number: TASCD24
• Device Lot Number: 1282247
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2024
• Is the Reporter a Health Professional?: Yes
• 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: 11/20/2024
• Supplement Report FDA Received Date: 01/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/22/2024
• 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 Age: 38 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic