MAUDE Adverse Event Report: BIOMET 3I TSX IMPLANT, 5.4MMD, 11.5MML; DENTAL IMPLANT

Catalog Number	TSX54B11
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).
Event or Problem Description
It was reported that when attempting to use an rsr which also was not torquing properly, the internal threads of the implant became damaged during the process.The implant was removed and the site was grafted.They will reattempt placement at a later date.
Additional Manufacturer Narrative
Zimvie received one (1) tsx54b11, (tsx implant, 5.4mmd, 11.5mml) for evaluation.One (1) unknown zimmer implant was not returned.Visual evaluation and a functional test were performed, there was debris found inside with slight damage.In-house screw does not disengage/thread.Dhr review was completed for the subject lot number 1275248.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 1275248 for similar events and no other complaint was identified.Review completed utilizing keywords: ¿dental : functional : damaged threads¿ the customer did not submit images for the reported event.Based on the investigation and risk management file review as per rm-00541-haz, the most likely root cause determined from the investigation was customer error.Therefore, based on the available information, a device malfunction did occur.The implants internal threads were damaged.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.The following sections have been updated: b4: date of this report.D9: device availability.G3: date received by manufacturer.G6: checked "follow-up".H2: checked follow-up type.H3: changed "no" to "yes".H6: entered evaluation codes.H10: added manufacturer narrative.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: TSX IMPLANT, 5.4MMD, 11.5MML
• 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: carlos gordian-arroyo ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5619713230
• MDR Report Key: 19801820
• Report Number: 0001038806-2024-01568
• Device Sequence Number: 8379436
• Product Code: DZE
• UDI-Device Identifier: 00844868045229
• UDI-Public: (01)00844868045229(17)281231(10)1275248
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K220978
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2024

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: TSX54B11
• Device Lot Number: 1275248
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/22/2024
• Supplement Report FDA Received Date: 11/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 18 YR
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic