MAUDE Adverse Event Report: BIOMET 3I OSSEOTITE® TAPERED CERTAIN® PREVAIL® IMPLANT 6/5 X 13MM; DENTAL IMPLANT

Model Number	XIITP6513
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/18/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Weight: patient weight not provided.
Event or Problem Description
It was reported that the implant became stripped during placement.Procedure was completed using a larger implant.
Event or Problem Description
No additional event information was received at the time of this report.
Additional Manufacturer Narrative
Multiple mdr reports were filed for this event.Please see associated report: 0001038806-2022-00818-1.This report is being submitted to relay additional information and device evaluation.The following sections are being reported: h6: type of investigation codes were updated: 3331 and 4109 and 4111.H6: investigation findings code was updated: 180.H6: investigation conclusion code was updated: 4307.The reported item was returned for investigation.Visual inspection of the as returned product identified worn markings and worn/damage drive feature.Based on the evaluation, the device malfunction has occurred.However, there is no existing nonconformance/capa/hhe/d/ie/product holds against the reported devices that could cause or contribute to the reported event.Zimmer biomet quality management system (qms) has controls in place to ensure the distribution of conforming product.Therefore, based on the available information, the products were likely within specifications and likely conforming when they left zimmer biomet.Dhr review was completed for the subject.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 for similar event and no other complaint was identified.The reported event could not be recreated due to the nature of the dental device and event and the complaint is related to the functional performance of the device.A definitive root cause could not be identified.However, based on the investigation and risk file review, the most likely cause determined from the investigation is torque applied during placement/seating exceeds recommended value, clinician inadvertently selects an instrument with the wrong drive feature to place/seat the implant, clinician inadvertently selects drill unit speed that exceeds recommended value for implant placement and final seating and the clinician does not follow the recommended protocol for product placement and final seating.No further investigation and no 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.

• Brand Name: OSSEOTITE® TAPERED CERTAIN® PREVAIL® IMPLANT 6/5 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: 14526209
• Report Number: 0001038806-2022-00817
• Device Sequence Number: 17306601
• Product Code: DZE
• UDI-Device Identifier: 00844868022220
• UDI-Public: (01)00844868022220(17)260609(10)2021050679
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/23/2022

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: Health Professional
• Device Expiration Date: 06/09/2026
• Device Model Number: XIITP6513
• Device Catalogue Number: XIITP6513
• Device Lot Number: 2021050679
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2022
• 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: 05/10/2022
• Supplement Date Received by Manufacturer: 11/02/2022
• Initial Report FDA Received Date: 05/27/2022
• Supplement Report FDA Received Date: 11/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/09/2021
• 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: 51 YR
• Patient Sex: Male