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

Catalog Number ILPC443U

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/08/2023

Event Type  malfunction  

Manufacturer Narrative

Zimvie complaint number (b)(4).E1: reporter phone: (b)(6).

Event Description

Doctor reported screw fracture.

Event Description

No further event information is available at the time of this report.

Manufacturer Narrative

Zimmer biomet complaint number (b)(4).Additional narrative zimvie received two (2) ilpc441u, (certain¿ low profile one-piece abutment 4.1mm(d) x 1mm(h)), one (1) ilpc443u (certain¿ low profile one-piece abutment 4.1mm(d) x 3mm(h) for evaluation.One (1) ilpc441u, (certain¿ low profile one-piece abutment 4.1mm(d) x 1mm(h)) was not returned for evaluation.Visual evaluation was performed, neither of the returned ilpc441u abutments were fractured.However, the returned ilpc443u was fractured at the threads.Additionally, all the abutments top ends had debris inside (no fragments).Dhr review by lot number could not be performed, as the item/lot number associated with the reported product is not available.However, zimvie quality management system (qms) has controls in place to ensure the distribution of conforming product.A complaint history review by item number was conducted for the ilpc443u dating back to 12 months from now.The complaint history review revealed that there are no existing non-conformances/capa/hhe/d/product holds for the reported product for similar event.Review completed utilizing keywords: dental : functional : fracture : abutment.Based on the investigation and risk management file review, the most likely root cause determined from the investigation was the material selection of the product is not adequate to withstand occlusal forces.Therefore, based on the available information, a device malfunction did occur.The abutment was fractured at the threads.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 4.1MM(D) X 3MM(H)
• Type of Device: 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 ; 5619713230
• MDR Report Key: 18463279
• MDR Text Key: 332263256
• Report Number: 0001038806-2024-02587
• Device Sequence Number: 1
• Product Code: NHA
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K092341
• Exemption Number: 5645646
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 02/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ILPC443U
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/04/2023
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic