MAUDE Adverse Event Report: BIOMET 3I UNKNOWN ABUTMENT

Catalog Number	UNKNOWN ABUTMENT
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the hex of a zirconia abutment fractured in the patients mouth.Doctor was able to remove the fractured abutment without any damage to the implant.
Additional Manufacturer Narrative
Zimmer biomet (b)(4).Age and date of birth unknown / not provided.Patient sex unknown / not provided.Weight unknown / not provided.Date of event unknown / not provided.Brand name unknown / not provided.Catalog, lot number, expiration date and unique identifier (udi) number unknown / not provided.Pma/510(k) number not available.Device manufacturer date.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
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 device with the naked eye and camera magnification revealed a fracture above the titanium ring at the emergence profile of the post.No pre-existing conditions were noted on the product experience report (per) the reported device was located on unknown tooth site when the event was reported.Pictures or x-ray images were not provided.A device history record (dhr) review could not be performed since the lot number associated to the item was not provided.However, zimmer biomet quality management system (qms) has controls in place to ensure the distribution of conforming product.A lot specific complaint history review is not conducted for patient specific product (psp) complaints.Patient specific products have a unique one time use lot number.Therefore, a lot specific history search for this complaint is not performed.Complainant reported that the hex of a zirconia abutment fractured in the patients mouth.The reported complaint was confirmed.A definitive root cause for this complaint could not be determined.The following sections have been updated: d9: device available for evaluation change ¿no' to 'yes'.H3: device evaluated by manufacturer: change ¿no' to 'yes'.H6: evaluation codes.

• Brand Name: UNKNOWN ABUTMENT
• Common Device Name: ABUTMENT
• 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: 12796184
• Report Number: 0001038806-2021-02166
• Device Sequence Number: 4774877
• Product Code: NHA
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2022

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: Lay User/Patient
• Device Catalogue Number: UNKNOWN ABUTMENT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 11/03/2021
• Supplement Date Received by Manufacturer: 06/03/2022
• Initial Report FDA Received Date: 11/11/2021
• Supplement Report FDA Received Date: 06/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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