MAUDE Adverse Event Report: ACUMED, LLC 2.3MM X 22MM LOCKING CORTICAL SCREW; SCREW, FIXATION, BONE

Model Number CO-T2322-S

Device Problem Unintended Movement (3026)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Event Description

It was reported the initial implant procedure occurred where the surgeon performed aculoc 2 plate insertion.One week post-surgery (exact event date unknown), it was reported one screw had backed out.The patient underwent a revision surgery for replacement of the screw.

Manufacturer Narrative

Manufacturing and inspection records were reviewed, and no anomalies were found.The returned screw was examined under magnification.Under magnification the batch number for the 2.3mm x 22mm locking cortical screw (part number co-t2322-s) was confirmed as 549415.The screw showed slight signs of wear on the head which is consistent with using a hex driver tip to drive the screws into the plate/bone.There is no excessive wear noted on the screw.It is unknown exactly where the screws were placed, if the screws were fully seated in the plate, and what kind of postoperative recovery was undertaken.There are no definitive signs of damage or wear to the screw.Therefore, based on the information received and the investigation performed, the root cause could not be determined.

• Brand Name: 2.3MM X 22MM LOCKING CORTICAL SCREW
• Type of Device: SCREW, FIXATION, BONE
• 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: 17302073
• MDR Text Key: 318831493
• Report Number: 3025141-2023-00356
• 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: Foreign,Health Professional,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CO-T2322-S
• Device Catalogue Number: CO-T2322-S
• Device Lot Number: 549415
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2023
• Date Manufacturer Received: 06/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/26/2021
• 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): Other
• Patient Race: Asian