MAUDE Adverse Event Report: ACUMED, LLC 2.0MM QUICK RELEASE DRILL; BIT, DRILL

Model Number 80-0318

Device Problems Device-Device Incompatibility (2919); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 02/16/2024

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

3 of 3.It was reported during a wrist fracture surgery, the surgeon put a 2.0mm drill guide to the plate through the targeting guide.The first drill guide threads broke when the surgeon tightened it.The next drill guide got stuck.The surgeon opened another acu-loc 2 instrument set and new drill guides.The surgery was completed after a 20-minute delay.There were no other adverse patient consequences reported.There are 3 related report numbers for this event 3025141-2024-00267 through 3025141-2024-00269.

Manufacturer Narrative

Manufacturing and inspection records were reviewed, and no anomalies were found.Two 2.0mm locking drill guide 4mm-32mm and one 2.0mm quick release drill were returned for evaluation.Several unspecified items likely involved with the engagement were not returned; this namely includes the plate (which the drill guides threaded into) and the targeting guide (which the drill guides were inserted through).The returned product was visually examined under magnification.On one of the returned locking drill guides, there was a hole torn within the threading itself; this tear damage spiraled along with the threading.The tear progressed along with the threading for approximately one turn of the threading in the tip region of the guide.This damage was present in the trough/root of the device's thread.The other returned locking drill guide was returned with a drill embedded within this guide.There were occasional instances of pitting or nicks in the peak/crests of the thread form at the tip of this guide.As previously stated, the returned drill was embedded in one of the returned locking drill guides which partially obscured the region of the drill shaft stuck within the guide and may inhibit visual evaluation as well as shaft diameter measurement of the drill.There were occasional instances of pitting or nicks on the edges of the flutes of this drill.Measurements for 80-0318 drill were taken in inches.All measurements and average were within the tolerance range.Given that up to ~2.3 inches of the shaft of the drill was embedded in one of the guides (as the drill was returned stuck in the guide), the measurements were taken from the ~1.84 inches of exposed smooth shaft.A functionality test specifically for guide-on-plate engagement of the guide that failed the reported engagement in the field was not conducted.The guide that had difficulty with the reported guide-on-plate engagement was damaged as previously stated to a point where it would not be feasible to attempt further similar engagements.Conducting usage testing would risk damaging the returned locking drill guide further.A functionality test specifically for drill-on-guide engagement failure could not be conducted as the drill and one guide were returned wholly stuck together.It was not possible to remove the drill from the guide to test the engagement.It was not possible to comprehensively investigate this incident without all relevant items present.This situation fundamentally involves part failures from a thread-on-thread engagement (i.E., threading the guide into the plate) in which the field only returned half of the relevant parts in that engagement (i.E., just the guides, not the plate).The field incident of drill-in-guide engagement failure was confirmed; however, the exact cause is unknown.The drill and guide cannot be separated for further evaluation.However, based on the information received and due to unknown surgical conditions, the root cause could not be determined.

• Brand Name: 2.0MM QUICK RELEASE DRILL
• 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: 18937687
• MDR Text Key: 338189730
• Report Number: 3025141-2024-00269
• Device Sequence Number: 1
• Product Code: HTW
• Combination Product (y/n): N
• Reporter Country Code: FI
• 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: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 80-0318
• Device Catalogue Number: 80-0318
• Device Lot Number: 403169
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2024
• Date Manufacturer Received: 03/27/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/27/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1