MAUDE Adverse Event Report: CONVENTUS FLOWER ORTHOPEDICS DISTAL RADIUS PLATE, STANDARD, LEFT, 3 HOLES

Model Number FDR 011

Device Problem Improper or Incorrect Procedure or Method (2017)

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

Event Date 10/07/2021

Event Type  malfunction  

Event Description

The event included the implantation of a plate that had exceeded its shelf life.The shelf life on the packaging was indicated to be (b)(6) 2021.The plate was implanted on (b)(6) 2021.Therefore, the plate had been implanted 7 days after the expiration date.

• Brand Name: DISTAL RADIUS PLATE, STANDARD, LEFT, 3 HOLES
• Type of Device: DISTAL RADIUS PLATE
• Manufacturer (Section D): CONVENTUS FLOWER ORTHOPEDICS; 100 witmer rd.; ste 280; horsham PA 19044
• MDR Report Key: 12701092
• MDR Text Key: 282635072
• Report Number: 3009996260-2021-00013
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00840118109932
• UDI-Public: 00840118109932
• Combination Product (y/n): N
• PMA/PMN Number: K123562
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial
• Report Date: 10/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2021
• Device Model Number: FDR 011
• Device Catalogue Number: FDR 011
• Device Lot Number: 2014003004
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/07/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/30/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 98