MAUDE Adverse Event Report: ACUMED, LLC 2.3MM X 18MM LKG VARIABLE ANGLE SCREW; SCREW, FIXATION, BONE

Model Number 30-2318

Device Problem Difficult to Remove (1528)

Patient Problems Foreign Body In Patient (2687); Insufficient Information (4580)

Event Date 09/01/2022

Event Type  malfunction  

Manufacturer Narrative

The investigation is pending.A follow up report will be submitted upon completion of the investigation.

Event Description

It was reported during an acu-loc 2 removal procedure, some 2.3 screws could not be removed because of a "cold melt issue".It was reported all devices were able to be explanted.Attempts to obtain further clarification regarding the event are being made.This report is related to report numbers 3025141-2022-00362, 3025141-2022-00364, and 3025141-2022-00365 for the other 2.3 screws involved in this event.

Manufacturer Narrative

Attempts to obtain further clarification regarding the event were made but were unsuccessful.Manufacturing and inspection records were reviewed, and no anomalies were found.The part number 30-2318 screw was returned for evaluation.Under magnification the batch number of the screw could not be identified due to damage on the screw head.Upon inspection, the screw was stuck in the head of the acu-loc vdr plate.The screw hex recess was significantly rounded and deformed and the shaft of the screw was fractured.The underside of the screw showed some slight deformation of threads just below the head from what was visible.There was significant bone ongrowth in and around the hole where the screw was located.Small threaded marks were apparent on the screw head around the hex recess indicating potentially an easy-out was used unsuccessfully to remove the screw.The screw could not be removed from the plate.The screw was measured to determine the location of fracture.The screw measured 0.310 inches, indicating that approximately 0.399 inches broke off of the screw.The scratches, dents and deformation observed on the surface of the plate and heads of the screws is possibly the result of the removal process.It could not be determined if the screws that broke were broken before or during the removal surgery.When screws were implanted for a period of time, bony ongrowth will adhere to the titanium which will result in an increase in torque necessary to remove the screws.This type of ongrowth was visible on the plate and some screws.If the screws broke during the removal surgery the increase in torque may have been enough to break the screws and/or driver.Based on the information received and the investigation performed, the root cause of the reported event could not be determined.

Manufacturer Narrative

Additional information regarding the event and patient status was received on 28 november 2022.The following information was provided by the surgeon: - this removal procedure on 01 september 2022 (event date) was to remove the devices from the patient as the patient is a pilates teacher and explained that in quadruped postures the volar area of the wrist bothered her.In addition, being a young woman with a daily and high-intensity sports activity, the surgeon recommended removing the material to prevent a sports accident from causing a peri-implant fracture in the future.-this removal surgery lasted 20-25 minutes.-a chisel had to be used to remove the screws and part of the volar cortex tore off.- the patient has an intraosseous screw fragment that has not been removed.- the surgeon had to widen the patient's scar and e made some bruises from having to touch/break the bone.- given the aforementioned broken bone, the surgeon advised patient immobilization for 3 weeks (in a normal removal a bandage is left for one week and without restriction of movement).-currently the patient is well and fully reincorporated to her work and sports practice.As a result of this new information h6.Health effect-clinical code (annex e) and health effect-impact code (annex f) were updated.

• Brand Name: 2.3MM X 18MM LKG VARIABLE ANGLE 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 ; 5035209618
• MDR Report Key: 15771344
• MDR Text Key: 307809408
• Report Number: 3025141-2022-00363
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K120903
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 30-2318
• Device Catalogue Number: 30-2318
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2022
• Date Manufacturer Received: 11/28/2022
• 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 Age: 34 YR
• Patient Sex: Female