MAUDE Adverse Event Report: ACUMED, LLC DRILL, LEFT HAND 1.5MM, QR; BIT, DRILL

Model Number 80-0399

Device Problem Difficult to Remove (1528)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/01/2023

Event Type  malfunction  

Event Description

1 of 5.It was reported during a routine removal surgery, when the surgeon tried to remove acutrak micro screw, the driver did not fit to the screw and the screw could not be removed.It was reported the surgeon then brought the patient back into the or for another surgery and used extraction devices to remove the screw but was unsuccessful.It was reported the surgery was prolonged, but it is unknown for how long.There were no other adverse patient consequences reported.This report is related to report numbers 3025141-2023-00728, 3025141-2023-00729, 3025141-2023-00730 and 3025141-2023-00731 for the other devices involved in this event.

Manufacturer Narrative

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

Manufacturer Narrative

The returned products were inspected under magnification.Upon inspection, the following observations were noted: drill, left hand 1.5mm, qr (part numbrt 80-0399).The returned 1.5mm drill showed some areas of minor denting and wear at the very tip as well as some minor discoloration within the cutting flutes at the end of the drill.Otherwise, there was no significant damage or wear visible along the length of the drill.Acutrak 2 micro trephine (part number 80-0213).The returned trephine showed some signs of damage on the teeth of the trephine.The internal surfaces of the teeth show some deformation and wear, being smoothed and deformed in some small areas.The internal surface of the trephine, close to the teeth also shows some scratching and wear.The slight wear shown on the teeth is indicative of the trephines being dull and worn primarily in the cutting area which can greatly affect their ability to remove screws from plates and bone.Micro removal tip (part number 80-0612).The returned micro removal tip showed no significant signs of use or damage anywhere along the length of the product.The internal surfaces of the removal tip, at the smaller, unthreaded end showed some scuffing and signs of minimal wear while the internal surfaces of the threaded side showed no signs of significant wear.The flute edges were in nearly new condition and showed no signs of wear.It is unclear why the returned product would be unable to remove the screws.1.5mm easyout, qr (part number 80-0598).The returned 1.5mm easyout showed some areas of minor denting and wear around the flute edges.The very tip of the easyout shows areas of deformation, with worn down edges that are scratched where the flutes of the easyout tapered into the tip's end.Otherwise, there was no damage or wear visible along the length of the easyout.When screws are 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.The screw used with these products was not returned.It is possible that the increase in torque required to remove the screws may have been enough to break, deform and wear away areas of the trephine, easyout, drill, and removal tip or that the visible minimal wear was present from prior use.Therefore, no definitive conclusion can be made at this time.Corrected data: investigation findings code (annex c) updated to: 3243.Investigation conclusions code (annex d) updated to: 4315.

• Brand Name: DRILL, LEFT HAND 1.5MM, QR
• Type of Device: BIT, DRILL
• 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: 18361010
• MDR Text Key: 331194024
• Report Number: 3025141-2023-00727
• Device Sequence Number: 1
• Product Code: HTW
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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,Followup
• Report Date: 12/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 80-0399
• Device Catalogue Number: 80-0399
• Device Lot Number: 282005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2023
• Date Manufacturer Received: 12/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/15/2012
• 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 Race: Asian