MAUDE Adverse Event Report: BIOMET 3I; UNKNOWN DENTAL DRIVER

Device Problem Device Damaged by Another Device (2915)

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

Event Date 09/12/2022

Event Type  malfunction  

Event Description

It was reported that driver and implant were engaged but while tryng to place implant, the driver spins inside implant and was impossible to place.Procedure was completed with other implant driver.Works fine with other implants.

Manufacturer Narrative

Zimmerbiomet complaint number (b)(4).Udi not available.Pma/510(k) number not available.Since the lot number and device will not be returned, identifying a definitive root cause will not be possible.Should additional information be received which identifies the product or indicates that the device may have caused or contributed to the event, an additional report will be submitted.

• Type of Device: UNKNOWN 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: 15558713
• MDR Text Key: 306320178
• Report Number: 0001038806-2022-01528
• Device Sequence Number: 1
• Product Code: NDP
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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
• Report Date: 10/07/2022

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/16/2022
• Initial Date FDA Received: 10/07/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: XIITP4311 LOT 2022040750
• Patient Age: 46 YR
• Patient Sex: Female