MAUDE Adverse Event Report: BIOMET 3I OSSEOTITE¿ IMPLANT 3.75 X 10MM; DENTAL IMPLANT

Catalog Number	OSS310
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).A1: patient identifier 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 blister containing the implant was broken.The procedure was successfully concluded.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Zimvie received one (1) oss310, (osseotite® implant 3.75 x 10mm) for evaluation.Visual evaluation of the as returned device identified the implant and its bundle mount attached to each other.The alleged damaged blister was not returned for evaluation, and the implant original packaging was not returned.Claim is non-verifiable as the conditions of the packaging when delivered to the customer are unknown.Functional testing to recreate the reported event could not be performed due to the nature of the device & event.Dhr review was completed for the subject lot number 2019011588.No deviations or non-conformances, which could have caused or contributed to the reported event, were noted as part of the dhr.Complaint history review was performed for the reported lot number 2019011588 for similar events and no other complaint was identified.Review completed utilizing keywords: packaging damaged.Based on the investigation and risk management file review, the most likely root cause determined from the investigation is mishandling of packaging outside of zimvie control.Therefore, based on the available information, the packaging malfunction could not be verified.The reported event/coob was non-verifiable since the condition of the product/packaging when received by the customer was unknown / non-verifiable.No further investigation or immediate capa / hhe/d escalation is required, as the complaint investigation did not confirm the products were 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¿ IMPLANT 3.75 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: 18146314
• Report Number: 0001038806-2023-02208
• Device Sequence Number: 7016064
• Product Code: DZE
• UDI-Device Identifier: 00844868013105
• UDI-Public: (01)00844868013105(17)240205(10)2019011588
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K063286
• 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
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 05/02/2024

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: 02/04/2024
• Device Catalogue Number: OSS310
• Device Lot Number: 2019011588
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2023
• 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: 11/16/2023
• Supplement Report FDA Received Date: 05/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/04/2019
• 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
• Patient Age: 45 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic