MAUDE Adverse Event Report: BIOMET 3I; DENTAL INSTRUMENT

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Zimmer biomet complaint number (b)(4).A1: patient identifier unknown / not provided.A2: age at time of the event unknown / not provided.A3: gender unknown / not provided.A4: patient weight unknown / not provided.B3: date of event unknown / not provided.D1: brand name unknown / not provided.D4: additional device information unknown / not provided.D10.Concomitant medical products xiitp4313, osseotite, tapered certain, prevail, implant 4/3 x 13mm lot 2022071439.E1: reporter name unknown / not provided.G4: premarket identification unknown / not provided.H4: device manufacturer date unknown / not provided.

Event Description

It was reported that the implant disengaged from the driver during surgery and fell.Procedure was completed with other implant.

Manufacturer Narrative

Zimmer biomet complaint number (b)(4).Zimvie did not receive one (1) unknown biomet driver for evaluation.Visual inspection could not be performed.The investigation has been performed based on the available information using the item number, and risk management file (rmf).Functional testing to recreate the reported event could not be performed due to the nature of the device and event.This complaint refers to the specific device being investigated for this complaint record.Device history record (dhr), sterilization, and complaint history review could not be performed, as the subject lot number associated with the unknown biomet driver is not available.Zimvie quality management system (qms) has controls in place to prevent the distribution of non-conforming product and ensure the product is within specifications.Based on the investigation and risk management file review, the most likely root cause determined from the investigation is incorrect techniques used.Therefore, based on the available information, a device malfunction could not be verified, without device receipt, the reported event is non-verifiable.No further investigation or immediate capa / hhe/d escalation is required, as the complaint investigation did not confirm the product was 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.

Event Description

No further event information is available at the time of this report.

• Type of Device: 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: carlos gordian-arroyo ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5619713230
• MDR Report Key: 17779114
• MDR Text Key: 323788264
• Report Number: 0001038806-2023-01773
• Device Sequence Number: 1
• Product Code: NHA
• Combination Product (y/n): N
• Reporter Country Code: PO
• Exemption Number: 5645646
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 02/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: DENTAL IMPLANT SEE H10 NARRATIVE
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic