MAUDE Adverse Event Report: BIOMET 3I CERTAIN¿ UNIVERSAL RATCHET EXTENSION IMPLANT DRIVER (LONG); DENTAL DRIVER

Model Number	IRE200U
Medical Device Problem Codes	Separation Failure (2547); Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that while placing the implant, driver got stuck inside the implant.Implant had to be removed.Tooth location 46, patient will have to return to place a new implant.After conversation with colleagues, they confirmed that sometimes can be hard to separate the components.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Age at time of the event unknown / not provided.Patient weight unknown / not provided.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).One (1) certain¿ universal ratchet extension implant driver (long) (ire200u) was returned for investigation.Visual evaluation of the as returned product identified signs of extended use, wear on the driver.Signs of use, damage on the implant likely from the removal process.Functional testing to recreate the reported event; verified the implant engaged, retained, and disengaged with returned ratchet extension as intended.A pre-existing condition noted on the per was moderate bone density (type ii).The reported implant was located on tooth # 46 (fdi) and was used, placed and removed on the same day.The length of the driver usage is unknown.Dhr review was completed for the subject lot numbers (2022091526 & 1224776).It was confirmed that all operations and inspections were executed as per applicable procedure.No deviations or non-conformance's, which could have caused or contributed to the reported event, were noted as part of the dhr.Lot numbers were inspected and passed all acceptance criteria by qa.Complaint history review was performed for the reported lot numbers (2022091526 & 1224776) for similar events and no other complaint was identified.Review completed utilizing keywords: does not disengage/release.Based on the available information, and functional testing device malfunction did not occur, and the reported event was unconfirmed.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: CERTAIN¿ UNIVERSAL RATCHET EXTENSION IMPLANT DRIVER (LONG)
• 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: 16399537
• Report Number: 0001038806-2023-00327
• Device Sequence Number: 6432976
• Product Code: NDP
• UDI-Device Identifier: 00844868029960
• UDI-Public: (01)00844868029960(17)290324(10)1224776
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 05/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: IRE200U
• Device Catalogue Number: IRE200U
• Device Lot Number: 1224776
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2023
• Supplement Date Received by Manufacturer: 05/16/2023
• Initial Report FDA Received Date: 02/17/2023
• Supplement Report FDA Received Date: 05/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/27/2019
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male