MAUDE Adverse Event Report: BIOMET 3I T3® PRO TAPERED IMPLANT 5/4MM (D) X 13MM (L); DENTAL IMPLANT

Catalog Number	T3PT5413
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimvie complaint cmp-(b)(4).A1: patient identifier is not provided / unknown.A2: patient age is not provided / unknown.A4: patient weight is not provided / unknown.B3: date of event is not provided / unknown.E1: initial reporter¿s email address are not provided / unknown.
Event or Problem Description
Per indicated: internal connection stripped.Symptoms as a result of the event: none reported.Surgical/medical intervention required for permanent damage: none reported.Additional appointment required: none reported.Was the procedure completed using another implant or another device? unknown.
Additional Manufacturer Narrative
This report is being submitted to report additional information.The following sections are being reported: d4: expiration date and unique identifier (udi) number.D9: device availability.H2: if follow-up, what type.H3: device evaluated by manufacturer.H4: device manufacturer date.H6: type of investigation.H6: investigation findings.H6: investigation conclusions.H10: additional narratives/data.Zimvie received one implant for evaluation.Visual evaluation of the as returned device identified the implant with signs of use, the implant drive feature was identified to be damaged.Dhr review was completed for the subject lot number.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 for similar events and no other complaint was identified.A definitive root cause could not be determined.Therefore, based on the available information, a device malfunction did occur.The reported event was confirmed with all the available information.No further investigation or immediate capa / hhe/d escalation is required, as the complaint investigation did not confirm the product was 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 or corrected information to report.

• Brand Name: T3® PRO TAPERED IMPLANT 5/4MM (D) X 13MM (L)
• Common Device Name: DENTAL IMPLANT
• 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 ; 5619713230
• MDR Report Key: 17243571
• Report Number: 0001038806-2023-01211
• Device Sequence Number: 5259998
• Product Code: DZE
• UDI-Device Identifier: 00844868046783
• UDI-Public: (01)00844868046783(17)270805(10)2022071096
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K213672
• 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
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2023

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: Health Professional
• Device Catalogue Number: T3PT5413
• Device Lot Number: 2022071096
• 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: 06/30/2023
• Supplement Report FDA Received Date: 12/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/04/2022
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic