MAUDE Adverse Event Report: BIOMET MICROFIXATION UNK 301 ELEVATOR; INSTRUMENT, MICROFIXATION

Catalog Number UNK 301 ELEVATOR

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2021-00063.Concomitant medical products: item# unk elevator crane pick ; lot# unk.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.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

It was reported approximately three (3) weeks ago, that the device had broken on an unknown date.No harm or consequences to the patient have been reported.Attempts have been made and no further information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Upon receiving additional information of the reported event, it was determined to be not reportable.The device was clarified to be bent, not broken, which is not considered a reportable malfunction.The initial report should be voided.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 available at the time of this report.

• Brand Name: UNK 301 ELEVATOR
• Type of Device: INSTRUMENT, MICROFIXATION
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 11308931
• MDR Text Key: 232582219
• Report Number: 0001032347-2021-00064
• Device Sequence Number: 1
• Product Code: EMJ
• Combination Product (y/n): N
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 02/16/2021

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 Catalogue Number: UNK 301 ELEVATOR
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/21/2021
• Initial Date FDA Received: 02/10/2021
• Supplement Dates Manufacturer Received: 02/11/2021
• Supplement Dates FDA Received: 02/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NI
• Patient Sequence Number: 1