MAUDE Adverse Event Report: ACUMEDLLC 2.3MM X 20MM LOCKING CORTICAL SCREW; SCREW, FIXATION, BONE

Model Number CO-T2320-S

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Bone Fracture(s) (1870)

Event Date 11/27/2019

Event Type  Injury  

Manufacturer Narrative

The screws that were returned were visually inspected under magnification.All screws show signs of usage such as surface scratches and anodization coming off due insertion or removal.Additional mdrs associated with this event: 3025141-2020-00005 - plate, 3025141-2020-00006 - screw 1, 3025141-2020-00007 - screw 2, 3025141-2020-00008 - screw 3, 3025141-2020-00009 - screw 4, 3025141-2020-00011 - screw 6, 3025141-2020-00012 - screw 7, 3025141-2020-00013 - screw 8, 3025141-2020-00014 - screw 9.

Event Description

During routine removal of orthopedic hardware, the surgeon was only able to remove one of the screws by turning the plate with the screw.During this process, the bone refractured and was treated with another screw.

• Brand Name: 2.3MM X 20MM LOCKING CORTICAL SCREW
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): ACUMEDLLC; 5885 ne cornelius pass road; hillsboro OR 97124
• Manufacturer (Section G): ACUMEDLLC; 5885 ne cornelius pass road; hillsboro OR 97124
• Manufacturer Contact: micki anderson ; 5885 ne cornelius pass road; hillsboro, OR 97124
• MDR Report Key: 9608691
• MDR Text Key: 178733588
• Report Number: 3025141-2020-00010
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K120903
• 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: 12/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CO-T2320-S
• Device Catalogue Number: CO-T2320-S
• Device Lot Number: 447382
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2019
• Date Manufacturer Received: 12/24/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/23/2018
• 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