MAUDE Adverse Event Report: ACUMED LLC 10.0MM X 2.0MM STEM; PROSTHESIS, ELBOW, HEMI-, RADIAL, STEM

Model Number TR-S1002-S

Device Problem Crack (1135)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/22/2018

Event Type  malfunction  

Event Description

During implantation of an arh radial head system, the surgeon reamed the bone to accept the stem.During reaming, the bone cracked at the cortex.

• Brand Name: 10.0MM X 2.0MM STEM
• Type of Device: PROSTHESIS, ELBOW, HEMI-, RADIAL, STEM
• 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: micki lehman ; 5885 ne cornelius pass road; hillsboro, OR 97124 ; 8886279957
• MDR Report Key: 7317894
• MDR Text Key: 101858467
• Report Number: 3025141-2018-00118
• 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: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: TR-S1002-S
• Device Catalogue Number: TR-S1002-S
• Device Lot Number: 426080
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/23/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/24/2017
• 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: 64 YR