MAUDE Adverse Event Report: ACUMED, LLC ARH SOLUTIONS 2 HEAD 20MM, RIGHT; PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER

Model Number 5001-0520R-S

Device Problem Misassembly by Users (3133)

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

Event Date 10/25/2022

Event Type  malfunction  

Event Description

It was reported during a primary surgery for radial head replacement, the first set of implants were incorrectly assembled on the back table.This was realized before the implants were placed in the patient.The surgeon and staff tried to remove the head from the long stem on the back table to allow proper orientation but were unsuccessful.A second set of implants was opened and was properly oriented.The procedure was completed.The issue with the first set of implants prolonged the procedure by 15 minutes.No adverse patient consequences were reported.This report is related to report number 3025141-2022-00377 for the long stem involved in this event.

Manufacturer Narrative

The device was not returned for evaluation.Manufacturing and inspection records were reviewed, and no anomalies were found.The reported event stated the implants were assembled incorrectly on the back table by operating room staff, and the head could not be removed from the long stem after incorrectly assembling resulting in the prolonged procedure.

• Brand Name: ARH SOLUTIONS 2 HEAD 20MM, RIGHT
• Type of Device: PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER
• 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: 15802243
• MDR Text Key: 307791464
• Report Number: 3025141-2022-00376
• Device Sequence Number: 1
• Product Code: KWI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131845
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5001-0520R-S
• Device Catalogue Number: 5001-0520R-S
• Device Lot Number: 490913
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/29/2020
• 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