MAUDE Adverse Event Report: ACUMED, LLC 8.0MM X 4.0MM STEM; PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER

Model Number TR-S0804-S

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bone Fracture(s) (1870)

Event Date 11/14/2023

Event Type  Injury  

Event Description

It was reported that during surgery the "stem insertion cracked radial shaft.Removal of implant.Cerclage with wire.Insert new implant.20-minute delay.Product is unavailable." the surgery was completed and there were no adverse patient consequences reported.This report is related to report number 3025141-2023-00701 for the reamer involved in this event.

Manufacturer Narrative

Manufacturing and inspection records were reviewed, and no anomalies were found for 8.0mm x 4.0mm stem (part number tr-s0804-s, lot number 500806).The results of the investigation are inconclusive as the device was not received for evaluation.Based on the information received, the root cause could not be determined.

• Brand Name: 8.0MM X 4.0MM STEM
• 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
• MDR Report Key: 18267759
• MDR Text Key: 329736943
• Report Number: 3025141-2023-00700
• 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: 12/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TR-S0804-S
• Device Catalogue Number: TR-S0804-S
• Device Lot Number: 500806
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/29/2020
• 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
• Patient Outcome(s): Required Intervention
• Patient Sex: Female