MAUDE Adverse Event Report: ACUMED LLC 3.5MM X 22.5MM CORTICAL SCREW; SCREW, FIXATION, BONE

Model Number CO-3225-S

Device Problem Bent (1059)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

The 3.5 mm cortical screw does not have any defects visible on it observed with the naked eye.Additional mdrs associated with this event: 3025141-2018-00232: ulna rod follow up 1, 3025141-2018-00234: radius rod follow up 1.

Event Description

A patient was involved in a motorcycle accident and broke both the ulna and radius in his arm.A radius rod and an ulna rod were implanted in a patient.Three days post op, the radius rod was found to be bent.It was explanted and the radius fracture treated with a forearm plate.

• Brand Name: 3.5MM X 22.5MM CORTICAL SCREW
• Type of Device: SCREW, 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: micki lehman ; 5885 ne cornelius pass road; hillsboro, OR 97124 ; 8886279957
• MDR Report Key: 7646258
• MDR Text Key: 112613723
• Report Number: 3025141-2018-00251
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K102998
• 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: 06/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 04/30/2021
• Device Model Number: CO-3225-S
• Device Catalogue Number: CO-3225-S
• Device Lot Number: 325514
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/15/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/02/2014
• 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 Outcome(s): Required Intervention
• Patient Age: 33 YR