MAUDE Adverse Event Report: ACUMED, LLC TOWER WRIST JOINT; APPARATUS, TRACTION, NON-POWERED

Model Number 10100014

Device Problem Break (1069)

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

Event Date 07/24/2023

Event Type  malfunction  

Event Description

It was reported during a surgery, the arc wrist tower was in locking position and staff was attempting to move the arc wrist tower to the table.However, when doing the transfer, it was reported "it fell apart at the joint".No other information was provided.

Manufacturer Narrative

Manufacturing and inspection records could not be reviewed as device model number and batch/lot number is unknown.The returned arc wrist tower was examined visually upon receipt.As received, the arc wrist tower wrist joint subassembly (part number 10100014), the rotating elbow teeth on wrist joint elbow and sleeve subassemblies a and b (part number 10100027 and part number 10100028) were not locking while the cam lever (part number 10150141) was in the neutral (down) position.Servicing was performed at the request of the customer.In the servicing process, four cap screw - mcmaster-carr (part number 92196a106) that were mounted to the spring housing (part number 10150139) were replaced due to rust.The friction disk (part number 10150145) was also replaced due to wear accumulating.The part was serviced by tightening the wrist joint cap screw (part number 10150147).The device was then inspected and met specifications.However, based on the information received and the investigation performed, the root cause could not be determined.

• Brand Name: TOWER WRIST JOINT
• 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 97124
• MDR Report Key: 17546335
• MDR Text Key: 321162876
• Report Number: 3025141-2023-00408
• 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: 08/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10100014
• Device Catalogue Number: 10100014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2023
• Date Manufacturer Received: 07/24/2023
• 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