MAUDE Adverse Event Report: BIOMET 3I OSSEOTITE® TAPERED CERTAIN® IMPLANT 4 X 15MM; DENTAL IMPLANT

Model Number	INT415
Medical Device Problem Code	Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the hexagon of the reported implant is damaged.The doctor confirmed that the procedure was completed with another implant and that the patient did not suffer any negative impact on his health as a result of the event.
Additional Manufacturer Narrative
Zimmer biomet complaint number: (b)(4).Weight 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).The following fields have been updated: b4: date of this report b5: describe event or problem d4: additional device information g3: date received by manufacturer g6: type of report h1: type of reportable event h2: follow up type h3: device evaluated by manufacturer h6: adverse event problem h10: additional narrative one osseotite tapered certain implant 4 x 15mm (int415) was returned for investigation.Visual evaluation of the as returned implant identified damage around the internal hex.Device history record (dhr) review for the lot (2021051437) had revealed no deviations nor non-conformances which could have caused or contributed to the reported event.All products were conforming at the time they left zimvie.Lot was inspected and passed all acceptance criteria by qa.Complaint history review was performed for the reported lot number (2021051437) for similar events (complaint category keywords: damaged drive feature) and no other complaint was identified.Therefore, based on the available information, device malfunction did occur, and the reported event was confirmed.

• Brand Name: OSSEOTITE® TAPERED CERTAIN® IMPLANT 4 X 15MM
• Common Device Name: DENTAL IMPLANT
• 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: 14694993
• Report Number: 0001038806-2022-00923
• Device Sequence Number: 5175566
• Product Code: DZE
• UDI-Device Identifier: 00844868006671
• UDI-Public: (01)00844868006671(17)260611(10)2021051437
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K063341
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2022

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 06/11/2026
• Device Model Number: INT415
• Device Catalogue Number: INT415
• Device Lot Number: 2021051437
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2022
• 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: 05/25/2022
• Supplement Date Received by Manufacturer: 10/19/2022
• Initial Report FDA Received Date: 06/15/2022
• Supplement Report FDA Received Date: 10/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/11/2021
• 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
• Patient Age: 50 YR
• Patient Sex: Male