MAUDE Adverse Event Report: ACUMED, LLC TOWER PARTS ASSEMBLY; APPARATUS, TRACTION, NON-POWERED

Model Number 10100001

Device Problem Device Dislodged or Dislocated (2923)

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

Event Date 09/07/2022

Event Type  malfunction  

Manufacturer Narrative

The device was received for evaluation.As received, the arc wrist tower pivot joint and pivot joint rotating plate( would not lock into place.The pivot joint female hex lock was stuck in the pivot joint rotating plate.When the pivot joint was toggled to rotate the pivot joint rotating plate, the pivot joint extraction rod was exposed along with the interior spring.Manufacturing and inspection records could not be reviewed as device batch/lot number is unknown.The root cause of the reported event could not be determined.

Event Description

It was reported during the procedure, the pivot joint separated from the base locking disc.The lever arm wouldn't latch, so the arm would toggled while locked.Due to this issue, an extra surgical tech was brought in to hold the tower in place.This issue resulted in a 15-20 minute delay in procedure.The patient remained stable, and there were not adverse consequences to the patient.

• Brand Name: TOWER PARTS ASSEMBLY
• Type of Device: APPARATUS, TRACTION, NON-POWERED
• 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 ; 5035209618
• MDR Report Key: 15522575
• MDR Text Key: 306421428
• Report Number: 3025141-2022-00327
• Device Sequence Number: 1
• Product Code: HST
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10100001
• Device Catalogue Number: 10100001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2022
• Date Manufacturer Received: 09/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Sex: Female