MAUDE Adverse Event Report: BIOMET 3I; ABUTMENT SCREW

Device Problem Fracture (1260)

Patient Problem Pain (1994)

Event Date 04/22/2022

Event Type  Injury  

Event Description

It was reported that when the patient fell, her crown broke resulting in the abutment screw to fracture.Pain was a reported consequence.

Manufacturer Narrative

Zimmer biomet complaint number (b)(4).Pma/510k: pma/510(k) number is unknown, device manufacture date: manufacturing date unknown.

Manufacturer Narrative

Multiple mdr reports were filed for this event.Please see associated report: 0001038806-2022-00726-1, 0001038806-2022-00727-1.This report is being submitted to relay additional information and device evaluation.Dhr review was completed for the subject lot numbers (2018011791, 2018110908).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, were noted as part of the dhr.Lot numbers were inspected and passed all acceptance criteria by qa.Dhr review and complaint history review by lot number could not be performed, as the lot number associated with the reported product (unknown biomet screw) is not available.Zimmer biomet quality management system (qms) has controls in place to ensure the distribution of conforming product within specifications.Sterilization records (op#0210) were reviewed and verified to have passed all sterilization activities with no issues or nonconformities identified.Complaint history review was performed for the reported lot numbers (2018011791, 2018110908) for similar events and no other complaint was identified.August post market trending was reviewed and there were no actionable events or corrective actions for the reported events (pain & fracture screw) or product (xiitp4311, xiitp6585, unknown biomet screw).No actionable items have been triggered that will affect complaint handling on our end for this month.Therefore, based on the available information, screw malfunction did occur, and the reported event fracture screw was confirmed.The reported event (pain) could not be verified as the exact details of event and patient anatomical conditions were unknown/non-verifiable.

Event Description

No additional event information was received at the time of this report.

Manufacturer Narrative

This report is being submitted to relay corrected information and additional information.Correction: h6 investigation codes 3331 and 4109 were reported in error as the item number and lot number were not provided.Please disregard these codes.

Event Description

No additional event information was received at the time of this report.

• Type of Device: ABUTMENT SCREW
• 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: 15243282
• MDR Text Key: 301470867
• Report Number: 0001038806-2022-01285
• Device Sequence Number: 1
• Product Code: NHA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/01/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Sex: Female