MAUDE Adverse Event Report: BIOMET 3I CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 5.0MM(D) X 2MM(H); DENTAL SCREW

Catalog Number	ILPC542U
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).
Event or Problem Description
Doctor reported fracture of low profile screw at tooth site 34.
Event or Problem Description
On a follow up, the doctor confirmed that a retaining screw fractured.The abutment was not fractured.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).The following fields have been updated: b4: date of this report b5: describe event or problem d4: additional device information d9: device availability g3: date received by manufacturer g6: type of report h1: type of reportable event h2: follow up type h3: device evaluated by manufacturer h4: device manufacturer date h6: adverse event problem h10: additional narrative additional information was obtained regarding evaluation findings.The clinician confirmed that the retaining screw fractured.Zimvie received one (1) ilpc542u, (certain¿ low profile one-piece abutment 5.0mm(d) x 2mm(h)) for evaluation.Visual evaluation was performed, the abutment had signs of use, the abutment wasn¿t fractured.The abutment had a retaining screw fractured inside its top end.Dhr review was completed for the subject lot number 2023040088.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 2023040088 for similar events and no other complaint was identified.Review completed utilizing keywords: dental : functional : fracture : screw.Based on the investigation and risk management file review, the most likely root cause determined from the investigation was the torque applied during placement/seating exceeds recommended value.Therefore, based on the available information, a device malfunction did occur.A retaining screw was fractured in the low-profile abutment.The reported event was 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.At this time, the complaint investigation has been completed and the record will be closed.If additional information is received, the record will be re-opened for further evaluation.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).After additional information was received, it was determined that this event no longer meets the criteria of a malfunction that if it were to recur would cause or contributed to a death and / or serious injury.As a result, the prior submission for mfr- 0001038806-2024-00918 submitted on october 9, 2024 is no longer considered a reportable event by the manufacturer and no further report will be submitted for this event.
Event or Problem Description
On a follow up, the doctor confirmed that a retaining screw fractured.The abutment was not fractured.

• Brand Name: CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 5.0MM(D) X 2MM(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: 19271398
• Report Number: 0001038806-2024-00918
• Device Sequence Number: 7034492
• Product Code: NHA
• UDI-Device Identifier: 00844868021025
• UDI-Public: (01)00844868021025(17)280414(10)2023040088
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/10/2024

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: ILPC542U
• Device Lot Number: 2023040088
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2024
• 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; Not provided
• Initial Report FDA Received Date: 05/08/2024
• Supplement Report FDA Received Date: 10/09/2024; 10/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/13/2023
• Is the Device Labeled for Single Use? (Y/N): No
• 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 Sex: Male
• Patient Ethnicity: Non Hispanic