MAUDE Adverse Event Report: ACUMED LLC 1.5 MM MULTISCREW/LAG SCREW CADDY; TRAY, SURGICAL, INSTRUMENT: CADDY

Model Number 80-2391

Device Problem Structural Problem (2506)

Patient Problem No Code Available (3191)

Event Date 02/07/2020

Event Type  malfunction  

Manufacturer Narrative

The lid (80-1820) and caddy (80-2391) interface was physically examined and is stuck as described in the description.The lid could not be removed by hand during this evaluation.The metal on metal contact between the sliding lid and the caddy base can cause wear over time due to the friction during the sliding on and off motion.The anodization of the components does help this motion, however it appears that the anodization has worn where the two components interface, which can be a factor in the lid getting stuck.Additional mdrs associated with this event: 3025141-2020-000034: lid.

Event Description

During surgical treatment of a routine finger fracture in an elderly patient, the surgeon requested a screw but the lid could not be removed from the caddy.This prevented the surgeon from finishing as he planned and surgery was delayed at least 15 minutes, trying to open the screw caddy.

• Brand Name: 1.5 MM MULTISCREW/LAG SCREW CADDY
• Type of Device: TRAY, SURGICAL, INSTRUMENT: CADDY
• 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: 9763634
• MDR Text Key: 184513819
• Report Number: 3025141-2020-00035
• Device Sequence Number: 1
• Product Code: FSM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141383
• 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,Followup
• Report Date: 02/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 80-2391
• Device Catalogue Number: 80-2391
• Device Lot Number: 338338
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2020
• Date Manufacturer Received: 03/27/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/15/2015
• 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
• Patient Weight: 45