MAUDE Adverse Event Report: ACUMED, LLC OLECRANON PLATE, STANDARD 5-HOLE LT; PLATE, FIXATION, BONE

Model Number 70-0304

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/23/2022

Event Type  malfunction  

Manufacturer Narrative

The results of the investigation are inconclusive as the device was not received for evaluation.Manufacturing and inspection records were reviewed, and no anomalies were found.

Event Description

It was reported during the procedure, when the doctor was placing the olecranon plate, they used a 2.7 x 26mm non-locking hexalobe screw to fix the plate.The surgeon requested an x-ray image to observe the placement, and he realized that it was too long for the patient.The surgeon decided to remove the plate and replace with a smaller plate.Once outside the patient, the medical team realized the tip of the screw was missing.Another x-ray image was taken to confirm if the missing fragment had remained inside the patient.The procedure was completed; however, the procedure was delayed by an hour.This report is related to report number 3025141-2022-00340 which is for the screw involved in this event.

• Brand Name: OLECRANON PLATE, STANDARD 5-HOLE LT
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): ACUMED, LLC; 5885 ne cornelius pass road; hillsboro OR 97124
• Manufacturer (Section G): ACUMED LLC; 5885 ne cornelius pass road; hillsboro OR 97124
• Manufacturer Contact: ellie wood ; 5885 ne cornelius pass road; hillsboro, OR 97124 ; 5035209618
• MDR Report Key: 15666177
• MDR Text Key: 303246286
• Report Number: 3025141-2022-00341
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: K102998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/21/2022

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: 70-0304
• Device Catalogue Number: 70-0304
• Device Lot Number: 529823
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/04/2022
• Initial Date FDA Received: 10/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/28/2021
• 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 Sex: Female
• Patient Ethnicity: Hispanic