MAUDE Adverse Event Report: BIOMET 3I OSSEOTITE¿ TAPERED CERTAIN¿ IMPLANT 5 X 13MM; DENTAL IMPLANT

Model Number	XIFNT513
Medical Device Problem Codes	Device Damaged Prior to Use (2284); Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that the cover screw is folded in its packaging.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).An osseotite tapered certain implant 5 x 13mm (xifnt513) was returned for investigation.Visual inspection of the as returned product identified worn markings due to usage and a fractured hex.Pre-existing patient factors, x-ray, tooth location are not relevant to the reported event.The length of the device usage is unknown.Dhr review was completed for the subject lot number (2022040394).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.Complaint history review was performed for the reported lot number (2022040394) for similar event and no other complaint was identified.Based on the available information, device malfunction did occur and the reported event was confirmed.
Event or Problem Description
The cover screw is folded in its packaging.Tm confirmed that the doctor had another cover screw in stock in order to place the implant and finish the procedure.

• Brand Name: OSSEOTITE¿ TAPERED CERTAIN¿ IMPLANT 5 X 13MM
• 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: 15844418
• Report Number: 0001038806-2022-01797
• Device Sequence Number: 20295046
• Product Code: DZE
• UDI-Device Identifier: 00844868022022
• UDI-Public: (01)00844868022022(17)270428(10)2022040394
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K130949
• 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): 03/16/2023

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 Model Number: XIFNT513
• Device Catalogue Number: XIFNT513
• Device Lot Number: 2022040394
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2022
• 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: 10/29/2022
• Supplement Date Received by Manufacturer: 03/09/2023
• Initial Report FDA Received Date: 11/22/2022
• Supplement Report FDA Received Date: 03/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/28/2022
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown