MAUDE Adverse Event Report: BIOMET 3I; SCREW

Device Problem Fracture (1260)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).Device has not yet been returned to manufacture.Product no returned to manufacturer.

Event Description

Doctor indicated that unknown screw fractured and piece got stuck in implant.

Manufacturer Narrative

No product was returned for inspection.No device lot number was provided so a device history record review and a complaint history review could not be performed.Appropriate documentation was reviewed and the following information was identified: without the returned product, there is not enough evidence to form a conclusion on the reported event.Therefore, the complaint is non-verifiable.A root cause cannot be determined.

Event Description

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

• Type of Device: SCREW
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 7817950
• MDR Text Key: 118529958
• Report Number: 0001038806-2018-00789
• Device Sequence Number: 1
• Product Code: DZL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 01/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/27/2018
• Patient Sequence Number: 1