MAUDE Adverse Event Report: ACUMED LLC 3.5MM X 24MM NON-LOCKING HEXALOBE SCREW; SCREW, FIXATION, BONE

Model Number 30-0263

Device Problems Break (1069); Appropriate Term/Code Not Available (3191)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

The returned plate was visually inspected under magnification to confirm fracture pattern.Under close inspection visually under magnification, the fracture of the plate occurred at the 6th hole from the proximal end.The fracture pattern shows mostly a shear force fracture.There is a corner that does have indications of fatigue.The plate is not bent or twisted out of shape.The predominant fracture pattern indicates a high energy event or too much stress caused the plate to break.X-rays were provided that show the failure of the plate was directly above the bone fracture.Generally, this is where the highest stress would have occurred during the high energy event and cause the plate to fail.Looking at the plate insertion surgery x-rays, there is a non-locking screw placed almost directly on top of the fracture site which could have come loose from the bone fragments and created a weak point which allowed the plate to fail.The x-ray also shows 13 screws were inserted in the plate and all 13 were returned.All 13 screws returned are non-locking screws.According to the surgical technique, the proximal end of the plate should receive locking screw.However, every screw in the plate are non-locking.This would not create the fixation needed across the fracture site.The screws that were returned were also visually inspected under magnification to confirm if they were a contributing factor to plate failure.All screws show signs of usage such as surface scratches and anodization coming off due insertion or removal.Additional mdrs associated with this event: 3025141-2020-00128: plate, 3025141-2020-00129: screw 1, 3025141-2020-00130: screw 2, 3025141-2020-00131: screw 3, 3025141-2020-00132: screw 4, 3025141-2020-00133: screw 5, 3025141-2020-00134: screw 6, 3025141-2020-00135: screw 7, 3025141-2020-00136: screw 8, 3025141-2020-00138: screw 10, 3025141-2020-00139: screw 11, 3025141-2020-00140: screw 12, 3025141-2020-00141: screw 13.

Event Description

Patient was implanted with a distal humerus plate and 13 screws on (b)(6) 2020.On (b)(6) 2020, x-rays were taken as the patient complained of pain and the plate was found to be broken and the bone was not healed.Hardware was removed in a second surgery on (b)(6) 2020.

• Brand Name: 3.5MM X 24MM NON-LOCKING HEXALOBE SCREW
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): ACUMED LLC; 5885 ne cornelius pass road; hillsboro, or
• Manufacturer (Section G): ACUMED LLC; 5885 ne cornelius pass road; hillsboro, or
• Manufacturer Contact: micki anderson ; 5885 ne cornelius pass road; hillsboro, or
• MDR Report Key: 10155353
• MDR Text Key: 195232765
• Report Number: 3025141-2020-00137
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K102998
• 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: 05/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 30-0263
• Device Catalogue Number: 30-0263
• Device Lot Number: 423001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2020
• Date Manufacturer Received: 05/22/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/05/2017
• 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
• Patient Age: 51 YR