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

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 02/10/2022

Event Type  malfunction  

Manufacturer Narrative

Additional mdrs associated wtih this event: 3025141-2022-00056: driver 1, 3025141-2022-00057: driver 2, 3025141-2022-00058: driver 3.

Event Description

A patient had been treated for a fracture of the scaphoid with a at2 mini screw.During another surgery to treat a scapholunate ligament tear, the surgeon tried to remove the at2 mini screw.The driver tips (3) broke during the removal, as did the screw.The broken screw remains implanted.There was a 45 minute delay in surgery as a result.

• 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 ; 5032071387
• MDR Report Key: 13726603
• MDR Text Key: 289867767
• Report Number: 3025141-2022-00059
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K944330
• 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: 02/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American