MAUDE Adverse Event Report: BIOMET MICROFIXATION MODIFIED BECK ELEVATOR; ELEVATOR, SURGICAL, DENTAL

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported an elevator fractured during a procedure.No adverse events have been reported as a result of the malfunction.

Event Description

It was reported an elevator fractured during a procedure.The fractured piece was removed from the patient.The procedure was completed with a second device.No adverse events have been reported as a result of the malfunction.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.

Manufacturer Narrative

Corrected lot number (d4) unique identifier (udi) number (d4) and h4 visual examination of the returned product identified item# sp-2359 lot# i17 (091917i17) was returned and also confirmed the reported fracture at the tip of the instrument.Review of the device history record(s) identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No further event information is available at this time.

• Brand Name: MODIFIED BECK ELEVATOR
• Type of Device: ELEVATOR, SURGICAL, DENTAL
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 11251360
• MDR Text Key: 229350474
• Report Number: 0001032347-2021-00032
• Device Sequence Number: 1
• Product Code: EMJ
• UDI-Device Identifier: 00841036138998
• UDI-Public: (01)00841036138998(10)021020B20
• 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,Followup
• Report Date: 06/18/2021

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: SP-2359
• Device Lot Number: 091917I17
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/05/2021
• Initial Date FDA Received: 01/29/2021
• Supplement Dates Manufacturer Received: 01/28/2021; 06/16/2021
• Supplement Dates FDA Received: 02/15/2021; 06/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1