MAUDE Adverse Event Report: BIOMET 3I UNKNOWN BIOMET SCREW; ABUTMENT SCREW

Model Number N/A

Device Problem Unintended Movement (3026)

Patient Problem No Information (3190)

Event Date 11/14/2018

Event Type  malfunction  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).Device catalog number and lot number not provided/unknown.Device not returned.

Event Description

It was reported that an unknown biomet screw loosened.The screw remains implanted.Tooth location 4.

Manufacturer Narrative

This report is being submitted to relay additional and corrected information.The following sections are being reported: b5: it was reported that an unknown biomet screw loosened at tooth location #4.The screw remains implanted.The patient will return for an additional appointment to remove the screw there was no report of patient injury.D1: unknown biomet screw d4: catalog number: unknown biomet screw lot number: unknown g4: 23 apr 2019 g7: follow up the reported device was not returned for evaluation as the device remains implanted in the patient's mouth.The reported event, " unknown biomet screw loosened at tooth location #4" could not be confirmed.Device history record review and complaint history review could not be performed, as reported device lot is unknown.Zimmer biomet quality management system has controls in place to ensure the distribution of conforming product within specifications a definitive root cause could not be determined for the reported event.Probable causes related to this event include customer error in screw torqueing.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

It was reported that an unknown biomet screw loosened at tooth location #4.The screw remains implanted.The patient will return for an additional appointment to remove the screw.There was no report of patient injury.

• Brand Name: UNKNOWN BIOMET SCREW
• Type of Device: ABUTMENT SCREW
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 8278898
• MDR Text Key: 134243730
• Report Number: 0001038806-2019-00071
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 04/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN BIOMET SCREW
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1