MAUDE Adverse Event Report: BIOMET 3I CERTAIN TITANIUM HEXED SCREW; DENTAL SCREW

Device Problem Unintended Movement (3026)

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

Event Date 04/17/2023

Event Type  malfunction  

Manufacturer Narrative

Zimvie complaint number (b)(4).A2: age and date of birth unknown / not provided.A3: gender unknown / not provided.A4: patient weight unknown / not provided.D4: lot/serial # unknown / not provided.D4: device expiration date unknown / not provided.D4: device udi number unknown / not provided.H4: device manufacturer date unknown / not provided.

Event Description

It was reported that the abutment screw loosened in the patient's mouth.The abutment was removed and replaced with an encode healing abutment.They took a new impression and sent it to the lab for remake.Unable to provide additional details but indicted that it was an encode titanium abutment.Doctor indicated that there was no damage to the implant internal threads.Will provide x-rays when available.

Manufacturer Narrative

Zimvie did not receive one (1) unknown biomet screw for evaluation.Visual inspection could not be performed.The investigation has been performed based on the available information using the item number, device history record (dhr) review, and risk management file (rmf).Dhr, sterilization, and complaint history review could not be performed, as the subject lot number associated with the [reported product] is not available.Zimvie quality management system (qms) has controls in place to prevent the distribution of non-conforming product and ensure the product is within specifications.The customer did not submit images for the reported event.Based on the investigation and risk management file review as per rm-00057-haz, the most likely root cause determined from the investigation are missing or confusing instructions for use and abutment screw is not torqued to specification.Therefore, based on the available information, a device malfunction could not be verified.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.

Event Description

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

• Brand Name: CERTAIN TITANIUM HEXED SCREW
• 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 ; 5617766700
• MDR Report Key: 16955901
• MDR Text Key: 315507234
• Report Number: 0001038806-2023-00960
• Device Sequence Number: 1
• Product Code: NDP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072642
• Exemption Number: 5645646
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/22/2023

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
• Device Operator: Other
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/26/2023
• Initial Date FDA Received: 05/18/2023
• Supplement Dates Manufacturer Received: 04/26/2023
• Supplement Dates FDA Received: 10/23/2023
• Was Device Evaluated by Manufacturer?: No
• 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