MAUDE Adverse Event Report: ACUMED LLC 3.5 X 30MM NL LOW PROFILE HEXALOBE SCREW; SCREW, FIXATION, BONE

Model Number 3025-35030

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Bacterial Infection (1735)

Event Date 01/10/2021

Event Type  Injury  

Manufacturer Narrative

The device was received for evaluation on 31 january 2022, and the evaluation was completed on 7 february 2022.Manufacturing and inspection records were reviewed, and no anomalies were found.The returned products were visually inspected under magnification.3.5 x 30 mm nl low profile hexalobe screw (pn 3025-35030) the 3.5 x 30mm nl low profile hexalobe screw had batch number confirmed as 446524.The head of the screw showed significant scratches denting and deformation.The hexalobe recess is significantly scratched and dented as well.Many of the threads across the length of the screw are shiny, dented and deformed indicating stripping.No other significant signs of damage are visible on the screw.It is not possible to determine if these signs of damage occurred during implant, use or explant.Possible reasons for the damage seen in the screw include damage incurred during the explant procedure or improper following of the surgical technique.Therefore, no definitive conclusion can be made.Quality will continue to monitor for trends.

Event Description

A polarus 3 proximal nail was implanted on (b)(6) 2020.On (b)(6) 2021, it was explanted due to nail loosening and infection.The technique used by the surgeon is thought to be the root cause of the issue.This was reported in medwatch 3500a report number: 3025141-2021-00119.Email communication was received from the field on (b)(6) 2022 indicating screw with part number 3025-35030 was also involved.The complaint record was updated with this information.The device was received for evaluation on 31 january 2022, and the evaluation was completed on 7 february 2022.This event is also related to reports 3025141-2022-00028 and 3025141-2022-00030 which were submitted for other screws involved in this event.

• Brand Name: 3.5 X 30MM NL LOW PROFILE HEXALOBE 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 ; 5032071387
• MDR Report Key: 13508301
• MDR Text Key: 285424662
• Report Number: 3025141-2022-00029
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 02/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 3025-35030
• Device Catalogue Number: 3025-35030
• Device Lot Number: 446524
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2022
• Date Manufacturer Received: 01/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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