MAUDE Adverse Event Report: ACUMED LLC ACU-LOC VDU PLATE LEFT STD; PLATE, FIXATION, BONE

Model Number 70-0045-S

Device Problems Entrapment of Device (1212); Physical Resistance/Sticking (4012)

Patient Problem Insufficient Information (4580)

Event Date 05/14/2021

Event Type  malfunction  

Manufacturer Narrative

The returned 2.0mm locking drill guide 4mm-32mm, 2.0mm quick release drill and acu-loc® vdu plate left std were examined visually under magnification.The drill guide cannot be manually unscrewed from the plate, and the drill bit is stuck with the cutting portion protruding from the bottom of the plate and the shaft sheared off at the end of the drill guide.The fracture pattern indicates a blunt and brittle fracture with jagged edges and some torsional markings at the center of the drill cross-section.Additionally, 360-degree markings can be seen at the tip of the head portion of the broken drill bit.The main thing to note is that the surgical technique instructs that the radiopaque targeting guide and locking bolt be used with the acu-loc plates to ensure proper placement and trajectory of the drill guide, drill, and screws.Improper trajectory of the drill guide into the plate can cause off-axis cross-threading, leading to the drill guide cutting into the plate and getting stuck.If the drill gets stuck within dense material as well as within an improperly assembled plate and drill guide, the combined forces can cause the drill bit to break when turning on the drill.Additional mdrs associated with this event: 3025141-2021-00049: drill, 3025141-2021-00051: screw, 3025141-2021-00052: drill guide.

Event Description

While implanting a aculoc vdu plate in the patient's wrist, the drill became stuck in the drill guide and could not be pulled out.The whole plate was removed and a second plate was successfully implanted.It is likely the drill was at an angle in the drill guide making it get stuck.There was a 15 minute delay in surgery.

• Brand Name: ACU-LOC VDU PLATE LEFT STD
• Type of Device: PLATE, 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: micki anderson ; 5885 ne cornelius pass road; hillsboro, OR 97124 ; 8886279957
• MDR Report Key: 11980036
• MDR Text Key: 260555147
• Report Number: 3025141-2021-00053
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K102998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/26/2024
• Device Model Number: 70-0045-S
• Device Catalogue Number: 70-0045-S
• Device Lot Number: 403772
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2021
• Date Manufacturer Received: 05/14/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/06/2017
• 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