MAUDE Adverse Event Report: ACUMED LLC .059 X 5" ST GUIDE WIRE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT: GUIDE WIRE

Model Number WS-1505ST

Device Problems Inadequacy of Device Shape and/or Size (1583); Physical Resistance/Sticking (4012)

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

Event Date 04/26/2019

Event Type  malfunction  

Manufacturer Narrative

Additional mdrs associated with this event: 3025141-2019-00235: plate.

Event Description

During the implantation of a ulna shortening plate, the wrong size guide wire was inserted into a guide wire hole in the plate and it became stuck.A second plate had to be used.There was a 30 minute delay in surgery.

• Brand Name: .059 X 5" ST GUIDE WIRE
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT: GUIDE WIRE
• 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 anderson ; 5885 ne cornelius pass road; hillsboro, OR 97124
• MDR Report Key: 8624856
• MDR Text Key: 145633663
• Report Number: 3025141-2019-00236
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K021321
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: WS-1505ST
• Device Catalogue Number: WS-1505ST
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/29/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 18 YR