MAUDE Adverse Event Report: BIOMET 3I OSSEOTITE¿ TAPERED CERTAIN¿ IMPLANT 5 X 10MM; DENTAL IMPLANT

Catalog Number	INT510
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2022
Type of Reportable Event	Malfunction
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.H4: device manufacturer date unknown / not provided.
Event or Problem Description
The doctor reports that the packaging of the box was not sealed on the inside.There was no negative impact on the patient's health and the procedure was concluded by placing another implant from the doctor's stock.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).One osseotite tapered certain implant (int510) was returned for investigation.Visual/physical evaluation of the as returned device identified no packaging.The device was returned outside of its original packaging and vial without any damage.Packaging could not be verified since it was not returned.Therefore, the reported event/coob could not be verified.Dhr review for the lot (2021071463) had revealed no deviations nor non-conformances which could have caused or contributed to the reported events.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 (2021071463) and no similar event or complaint was found.(complaint category keyword: damaged or un-sealed sterile barrier).Based on the investigation and risk management file review, the most likely root cause determined was improper handling of device/packaging outside of zimvie controls.Therefore, based on the available information, the reported malfunction and event/coob could not be verified.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 or Problem Description
No further event information is available at the time of this report.

• Brand Name: OSSEOTITE¿ TAPERED CERTAIN¿ IMPLANT 5 X 10MM
• 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 ; 5619713230
• MDR Report Key: 17778583
• Report Number: 0001038806-2023-01768
• Device Sequence Number: 6551478
• Product Code: DZE
• UDI-Device Identifier: 00844868006695
• UDI-Public: (01)00844868006695(17)260824(10)2021071463
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K063341
• 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): 03/19/2024

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: 08/23/2026
• Device Catalogue Number: INT510
• Device Lot Number: 2021071463
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2023
• 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: 09/20/2023
• Supplement Report FDA Received Date: 03/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/23/2021
• 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): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic