MAUDE Adverse Event Report: ACUMED LLC 3.0MM X 270MM ULNA ROD; ROD, FIXATION, INTRAMEDULLARY

Model Number UL-3027-S

Device Problem Bent (1059)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

Additional mdrs associated with this event: 3025141-2018-00234: radius rod.

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.

Manufacturer Narrative

Additional mdrs associated with this event: 3025141-2018-00234: radius rod, follow up 1.3025141-2018-00251: screw.

• Brand Name: 3.0MM X 270MM ULNA ROD
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• 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: 7580459
• MDR Text Key: 110452773
• Report Number: 3025141-2018-00232
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K915613
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 05/31/2019
• Device Model Number: UL-3027-S
• Device Catalogue Number: UL-3027-S
• Device Lot Number: 274414
• Was Device Available for Evaluation?: No
• 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?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/21/2012
• 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