MAUDE Adverse Event Report: BIOMET 3I CERTAIN LOW PROFILE 17 ABUTMENT 4.1MM(D) X 4MM(H); DENTAL SCREW

Catalog Number	ILPAC4417
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Inflammation (1932); Osteolysis (2377)
Date of Event	04/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).A4: weight unknown / not provided 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
It was reported that the screw fractured in the implant at tooth location #6 and was unable to be retrieved.
Additional Manufacturer Narrative
This report is being submitted to relay additional information and device evaluation.The following sections are being reported: h6: type of investigation codes were added: 4109, 4111 and 3331.H6: investigation findings code was added: 3252.H6: investigation conclusions code was added: 4307.Zimvie received the reported abutment for evaluation.Visual evaluation was performed, a fracture has been identified inside implant.Dhr review was completed for the subject lot number 2022031313.No deviations or non-conformances, which could have caused or contributed to the reported event, were noted as part of the dhr.Complaint history review was performed for the reported lot number 2022031313 for similar events and no other complaint was identified.Based on the investigation and risk management file review, the most likely root cause determined from the investigation was clinician incorrectly engages abutment screw into implant.Therefore, based on the available information, device malfunction did occur.The fracture has been identified inside implant.The reported event is confirmed.No further investigation or immediate capa / hhe/d escalation is required, as the complaint investigation did not confirm the products were nonconforming at the time of distribution, and no new failure mode, harm, or hazardous situation was identified through the investigation performed.
Event or Problem Description
No additional event information received at the time of this report.

• Brand Name: CERTAIN LOW PROFILE 17 ABUTMENT 4.1MM(D) X 4MM(H)
• Common Device Name: DENTAL 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: carlos gordian-arroyo ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5619713230
• MDR Report Key: 19333733
• Report Number: 0001038806-2024-01017
• Device Sequence Number: 19608427
• Product Code: NHA
• UDI-Device Identifier: 00844868037569
• UDI-Public: (01)00844868037569(17)270503(10)2022031313
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: K092341
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2024

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 Catalogue Number: ILPAC4417
• Device Lot Number: 2022031313
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/16/2024
• Supplement Report FDA Received Date: 10/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/02/2022
• 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 Age: 72 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic