MAUDE Adverse Event Report: BIOMET 3I; BIOMET ABUTMENT

Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).Patient weight: not provided.Event date: not provided.Device brand name: not provided.Device catalog/ lot number: not provided.Pma/510(k) number: not provided.
Event or Problem Description
It was reported that a biomet abutment screw fractured within the implant.Implant was removed and site was grafted.Tooth location 30.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).The reported device was returned for investigation.Visual inspection of the returned products identified one implant with fractured screw inside of it.Additionally, implant body identified to have damaged likely from removal process.Functional testing and dimensional analysis could not be performed since the screw was fractured and its piece remained inside the implant.The reported device had been located on tooth site 30 and was implanted for approximately 4 years and 9 months.X-ray and picture images were not provided.Device history record (dhr) and complaint history review could not be performed for unk abutment screw as the catalog and lot number was not available.However, zimmer biomet quality management system (qms) has controls in place to ensure the distribution of conforming products within specifications.Complainant reported that a biomet abutment screw fractured within the implant.Implant was removed and site was grafted.The reported complaint was confirmed.A definitive root cause for this complaint could not be determined.The following sections have been updated: h3: device evaluated by manufacturer: change ¿no' to 'yes' h6: evaluation codes h10: additional narrative.

• Common Device Name: BIOMET ABUTMENT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 11986269
• Report Number: 0001038806-2021-00992
• Device Sequence Number: 4698555
• Product Code: NHA
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• 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: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 10/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/17/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/17/2021
• Supplement Date Received by Manufacturer: 09/22/2021
• Initial Report FDA Received Date: 06/11/2021
• Supplement Report FDA Received Date: 10/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BOST513.; BOST513
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 50 YR