MAUDE Adverse Event Report: BIOMET 3I CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 3.4MM(D) X 3MM(H); DENTAL SCREW

Catalog Number	ILPC343U
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
The doctor reports that all 7 screws fractured by the body.The doctor does not report the affected dental positions.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).A1 patient identifier unknown / not provided.A2: age and date of birth unknown / not provided.A3: patient sex unknown / not provided.A4: weight unknown / not provided.B3: date of event unknown / not provided.D10: associated devices: ilpac3217 2021060368.2x ilpc31u 2022110579.4x lpctsh 2022090661.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).It was reported that all 7 screws fractured by the body.Zimvie received one (1) ilpc343u, (certain low profile one-piece abutment 3.4mm(d) x 3mm(h)) for evaluation.Visual evaluation was performed, abutment received with a fractured screw inside top.This complaint refers to the specific device ilpc343u.Dhr review was completed for the subject lot number 2022110579.No deviations or non-conformance's, 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 2022110579 for similar events and no other complaint was identified.Review completed utilizing keywords: dental : functional : fracture : screw the customer did not submit images for the reported event.Based on the investigation and risk management file review, the most likely root cause determined from the investigation were missing or confusing instructions for use and clinician incorrectly engages abutment screw into implant therefore, based on the available information, a device malfunction did occur.The a fracture at the threads of the screw.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.

• Brand Name: CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 3.4MM(D) X 3MM(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: susanne taylor ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5617766700
• MDR Report Key: 16760001
• Report Number: 0001038806-2023-00763
• Device Sequence Number: 6046889
• Product Code: DZE
• UDI-Device Identifier: 00844868021094
• UDI-Public: (01)00844868021094(17)271129(10)2022110579
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• 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
• Report Date (Section B): 09/26/2023

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: Other
• Device Catalogue Number: ILPC343U
• Device Lot Number: 2022110579
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2023
• 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: 03/27/2023
• Supplement Date Received by Manufacturer: 03/27/2023
• Initial Report FDA Received Date: 04/18/2023
• Supplement Report FDA Received Date: 09/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/29/2022
• 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 Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic