MAUDE Adverse Event Report: BIOMET 3I OSSEOTITE TAPERED IMPLANT 5 X 8.5MM; DENTAL IMPLANT

Model Number	NT585
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).
Event or Problem Description
It was reported that at the moment of the surgery the doctor noticed the implant barrier was opened.Doctor completed the procedure placing another implant from stock.
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).The following sections have been updated: h3: device evaluated by manufacturer: change ¿no' to 'yes.' one osseotite® tapered implant 5 x 8.5mm (nt585) was returned for investigation.Visual inspection of the as returned product identified that the outer box shows signs of crushing.The outer and inner tray are already opened, and adhesive residue is present along the edge of the trays as normal.No signs of breaks in the seal were found.The implant and mount were also returned with no signs of damage or usage.The customer has indicated that the device was not used in a patient.The reported event could not be recreated due to the nature of the dental device and event (packaging damage).The customer has provided additional pictures of the packaging as it was stated to have been upon delivery, which shows similarly that the packaging has been opened.Device history record review was completed for the subject lot number 2019101981.It was confirmed that all operations and inspections were executed as per applicable procedure.No deviations or non-conformances, which could have caused or contributed to the reported event was noted as part of the dhr.Lot was inspected and passed all acceptance criteria by qa following final packaging and sterilization.Complaint history review was performed for the reported lot number (2019101981) for similar event and no other complaint was identified utilizing keyword(s) 'damaged' and 'packaging'.June post market trending was reviewed and there were no actionable events or corrective actions for the reported event(s) (damaged sterile packaging) or product (nt585).Therefore, based on the available information, device malfunction could not be verified and the reported event was non-verifiable.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: OSSEOTITE TAPERED IMPLANT 5 X 8.5MM
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 11639849
• Report Number: 0001038806-2021-00577
• Device Sequence Number: 19623152
• Product Code: DZE
• UDI-Device Identifier: 00844868012108
• UDI-Public: (01)00844868012108(17)241107(10)2019101981
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K063286
• 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): 09/03/2021

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: 11/07/2024
• Device Model Number: NT585
• Device Catalogue Number: NT585
• Device Lot Number: 2019101981
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/17/2021
• Supplement Date Received by Manufacturer: 08/27/2021
• Initial Report FDA Received Date: 04/09/2021
• Supplement Report FDA Received Date: 09/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1