MAUDE Adverse Event Report: ACUMED LLC; SCREW, FIXATION, BONE

Device Problem Physical Resistance/Sticking (4012)

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

Event Date 05/14/2021

Event Type  malfunction  

Manufacturer Narrative

Additional mdrs associated with this event: 3025141-2021-00049: drill.3025141-2021-00052: drill guide.3025141-2021-00053: plate.

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.

• 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: micki anderson ; 5885 ne cornelius pass road; hillsboro, OR 97124 ; 8886279957
• MDR Report Key: 11980033
• MDR Text Key: 260554301
• Report Number: 3025141-2021-00051
• 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: 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/14/2021
• Initial Date FDA Received: 06/10/2021
• Was Device Evaluated by Manufacturer?: No
• 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