MAUDE Adverse Event Report: BIOMET 3I INTERNAL CONNECTION UNIVERSAL PLACEMENT DRIVER TIP - LONG; DENTAL INSTRUMENT

Catalog Number	IIPDTUL
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/03/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The doctor reported that during the procedure, the implant at tooth site # 26 remained stuck to the driver and cannot be separated.The doctor reported that the torque used was 50 ncm.The procedure was completed by placing another implant of the same reference.There was no impact on the patient's health.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).A1: patient identifier unknown / not provided.A2: age at time of the event unknown / not provided.A4: patient weight unknown / not provided.D4: additional device information unknown / not provided.D10.Concomitant medical products int585, osseotite tapered certain implant 5 x 8.5mm lot 2021090671.H4: device manufacturer date unknown / not provided.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Zimvie received one (1) iipdtul, (internal connection universal placement driver tip - long) for evaluation.Visual evaluation / functional test was performed, stuck inside returned implant and cannot be disengaged.Dhr review was completed for the subject lot number 1241843.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 1241843 for similar events and 1 other relevant complaint(s) was identified.Review completed utilizing keywords: dental : functional : does not disengage/release.Based on the investigation and risk management file review , the most likely root cause determined from the investigation was the clinician does not follow the recommended guidance for usage in surgical manual therefore, based on the available information, a device malfunction did occur.The driver is stuck inside returned implant and cannot be disengaged.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.At this time, the complaint investigation has been completed and the record will be closed.If additional information is received, the record will be re-opened for further evaluation.

• Brand Name: INTERNAL CONNECTION UNIVERSAL PLACEMENT DRIVER TIP - LONG
• 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 ; 5619713230
• MDR Report Key: 17849840
• Report Number: 0001038806-2023-01900
• Device Sequence Number: 3352750
• Product Code: NDP
• UDI-Device Identifier: 00844868038870
• UDI-Public: (01)00844868038870(17)251203(10)1241843
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2024

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: 12/02/2025
• Device Catalogue Number: IIPDTUL
• Device Lot Number: 1241843
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2023
• 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: 10/02/2023
• Supplement Report FDA Received Date: 03/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/03/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: DENTAL IMPLANT SEE H10 NARRATIVE
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic