MAUDE Adverse Event Report: ACUMED, LLC Ø0.7 X 150MM GUIDE WIRE, DOUBLE TROCAR; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number 35-0026

Device Problems Break (1069); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pain (1994)

Event Date 01/17/2024

Event Type  malfunction  

Manufacturer Narrative

Manufacturing and inspection records could not be reviewed as device batch/lot number is unknown.Based on the information received, the root cause could not be determined.

Event Description

5 of 5 it was reported during a revision surgery due to complaints of pain, the surgeon attempted to remove two 16mm, 2.0 nano acutrak 3® bone screw (part number 3050-20016) with two t6 cannulated hexalobe driver (part number 80-4149).The ø0.7 x 150mm guide wire, double trocar (part number 35-0026) was inserted when the driver slipped over the guidewire breaking the diver tips and stripping out the screw head interfaces.The surgery was completed after a one-hour delay with a hardware removal set.No other adverse patient consequences were reported.There are 5 related report numbers for this event 3025141-2024-00065.

• Brand Name: Ø0.7 X 150MM GUIDE WIRE, DOUBLE TROCAR
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: 18679961
• MDR Text Key: 335077037
• Report Number: 3025141-2024-00069
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 02/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 35-0026
• Device Catalogue Number: 35-0026
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/18/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1